Pharmaceutical Industry An2

“Ovidius” University of Constanţa
Faculty of Letters
Department of Modern Languages
For Non-Literary Faculties
ENGLISH
FOR PHARMACY STUDENTS
Sources:
Michaela Bücheler et al., English for the Pharmaceutical Industry, Express series, Oxford University Press, Oxford, 2010.
Michael Vince, Paul Emmerson, First Certificate Language Practice with key, Macmillan, Oxford, 2003.
D. G. Mackean, Dave Hayward, Biology for Cambridge IGCSE 3rd Edition, Hodder Education, London, 2014.
Contents
Unit 1
Kick-off p.3
Paraphrasing and summarizing p.11
Grammar: Countable and uncountable nouns p.13
Unit 2
Substance discovery and product development p.18
Grammar: Articles p.28
U nit 3
Quality assurance and auditing in the pharmacy p.32
Grammar: making comparisons_______p.44
Unit 4
Ready for testing in live organisms______p.48
Grammar: Phrasal verbs 1_______p.60
Unit 5
Drug safety and regulatory affairs______p.64
Grammar: Verbs followed by –ing or infinitive_____p.76
Unit 6
Production and packaging_______p.78
Grammar: Verb/adjective + prepositions_____p.90
Unit 7
Test yourself_______p.92
Useful phrases______p.98
Grammar consolidation______p.101
Paraphrasing and summarising
Writing information in your own words is a highly acceptable way to include the ideas of other
people in your writing. There are two ways you can do this: paraphrasing and summarising. It is
very important, however, to paraphrase and summarise correctly because there is a fine balance
between acceptable and unacceptable paraphrasing and summarising (plagiarism). You need to
learn the rules so you are able:
1. To paraphrase information NOTE: APA referencing
2. To summarise information style is used in used in this
fact sheet.
1. To paraphrase information
To paraphrase is to rewrite something using different words without changing the original
meaning. This is what is usually meant by the phrase ‘in your own words’. The paraphrase should
be clearer and more easily understood than the original and is often about the same length.
Paraphrases are a good alternative to using direct quotations.
In your writing, you may make a paraphrase of:
● short sections of text (e.g. phrases, sentences)
● longer sections of text (e.g. a paragraph)
● information that explains tables or figures.
STEPS FOR PARAPHRASING

1. Read the text carefully. Underline, or note, any important subject-specific words.
2. Look up any difficult words, and try to find synonyms for them.
3. Try to find different ways of expressing the information in the groups of words (phrases).
4. Rewrite each sentence. Try to simplify the sentence structure and the vocabulary without changing
the meaning.
5. Put you text out of sight and write your paraphrase from memory.
6. Revise what you have written, comparing it to the original. Your paraphrase should clarify the
original, but be written clearly in your own words.
7. Do not forget to use an in-text reference at the start or end of your paraphrase.
EXAMPLE OF CORRECTLY PARAPHRASED INFORMATION
ORIGINAL TEXT ACCEPTABLE PARAPHRASED TEXT

(45 words) (56 words)
Traditionally, in oral and written discourses, the If the gender of a person was not known or was
masculine pronoun 'he' was used as a pronoun to unimportant to the meaning of oral or written texts, it
refer to a person whose gender was unknown or was customary to use the masculine form of 'he'
irrelevant to the context. Recently, this usage has when a pronoun was required; however, there has
come under criticism for supporting gender-based been growing concern about this practice in modern
stereotypes and is increasingly considered usage because it appears to privilege stereotypes
inappropriate (Smith, 2010, p. 24). based on gender (Smith, 2010, p. 24).
ASSESS YOUR PARAPHRASE
 The MEANING is the same.

 Most of the words have been changed.
 The sentences have been significantly restructured.
 This is about the same length as the original writing
 The information is correctly referenced.
11
2. To summarise information
Many assignments are accompanied by a compulsory and/or suggested reading list. No doubt you
have often wondered how your 2 000 or so word assignment could possibly incorporate all those
resources that are meant to inform your writing. Summaries of material may be used to give an
overview of the work of one or more authors, so they are much shorter than the original text.
Because they are very brief outlines of arguments made, they are very useful when you want to
indicate the support given for and/or against some position you are taking in your argument.
In your writing you may make a summary from:
● one or more paragraphs
● an entire article, chapter or complete work
● a combination of readings with similar ideas.
STEPS FOR SUMMARISING

1. If you are reading longer texts (e.g. a chapter, a journal article), skim read the information. Note
sub-headings, the first and last paragraphs and topic sentences.
2. Read the text carefully using a dictionary.
3. Reread a difficult text several times.
4. Write notes in point form using key words and ideas.
5. Put your text away and write your summary from your notes.
6. Refer back to the original to make sure that your summary truly reflects the writer's ideas and
strength of opinion (degree of certainty on this topic).
7. Do not forget to use an in-text reference at the start or end of your summary.
EXAMPLE OF CORRECTLY SUMMARISED INFORMATION
ORIGINAL TEXT ACCEPTABLE SUMMARISED TEXT

(103 words) (31 words)
“For most people, writing is an extremely difficult Inexperienced and even skilled writers can feel a
task if they are trying to grapple in their language great deal of anguish when faced with writing tasks;
with new ideas and new ways of looking at them. however, this response can be managed by
Sitting down to write can be an agonising recognising and coping with personal avoidance
experience, which doesn't necessarily get easier strategies (Taylor, 1989, p. 3).
with the passage of time and the accumulation of
experience. For this reason you need to reflect
upon and analyse your own reactions to the task of
writing. That is to say, the task will become more
manageable if you learn how to cope with your own
particular ways avoiding putting off the moment
when you must put pen to paper” (Taylor 1989, p.
3).
ASSESS YOUR SUMMARY

 The MEANING is the same.
 The summary keeps the degree of certainty of the writer.
 This is a much shorter version of the original writing.
 The source/s of information is/are clearly referenced.
12
FIRST C E R T I F I C A T E L A N G U A G E P R A C T I C E
Underline the most suitable w o r d in each sentence.
a) Different countries have different weather/weathers.

b) All areas of the skin are in fact covered in tiny hair/hairs.
c) We've looked at the menu and we'd all like chicken/chickens.
d) Jack is a millionaire and owns a lot of business/businesses.
e) Have you a copy of the complete work/works of Dante?
f) None of the passengers had insured their baggage/baggages.
g) Students must pass their paper/papers to the front.
h) I'm afraid we can't find cheap accommodation/accommodations for all of you.
2 Complete each sentence w i t h a/an, some or by leaving the space blank.
a) When the play ended, there was / lengthy applause.

b) I can't come out tonight. I have homework to do.
c) Sue received excellent education.
d) The inside is strengthened with steel frame.
e) My friends bought me coffee maker for my birthday.
f) David has just bought new furniture.
g) Let me give you advice.
h) My trousers need pressing. Can you lend me iron?
3 Underline the most suitable w o r d in each sentence.
a) I would love to go on a long journey/travel by train.

b) What's the latest news? Can I look at your paper/journal?
c) Here's your ticket. Do you have any luggage/suitcase?
d) Don't forget to buy a sliced bread/loaf.
e) Why don't we leave the car in this car park/parking.
f) I can't come to work today. I have a bad cold/flu.
g) Excuse me sir, but do you have a licence/permission for this gun?
h) Brighton has quite a good beach/seaside.
120
13
G R A M MR
A 2 1 COUNTABLE A N D UNCOUNTABLE NOUNS
4 Put one suitable w o r d in each space.
a) I'm looking for .accomodation . Do you know anywhere I can stay?

b) Take my , don't go out alone after dark.
c) The government plans to improve by paying teachers more.
d) Can you lend me some ? I want to print out a letter.
e) I need some about language schools. Can you help me?
f) Richard is unemployed, and he is looking for a
g) Could I have some ? Those apples and oranges look nice.
h) I used to have long , but I had it cut.
i) I can't do this on my own. Could you give me some ?
j) If you can't undo the knot, cut the string with some
5 Complete each sentence w i t h the most suitable w o r d or phrase.
a) I like your new trousers. Where did you buy B ?

A) it B) them C) them both D) them all
b) There is always a very large at the church I go to.
A) congregation B) audience C) spectator D) company
c) The local has agreed to repair the road outside our house.
A) government B) people C) council D) jury
d) When the police arrived, we were pleased to see
A) him B) him or her C) it D) them
e) The car turned over, but luckily it didn't suffer serious
A) damage B) injury C) damages D) injuries
f) Sorry, I'm late, but I had a lot of to do.
A) job B) work C) task D) labour
g) Julie bought herself a complete new for winter.
A) outfit B) cloth C) clothing D) wear
h) I feel like going out tonight. Let's go to a/an
A) dancing B) night C) club D entertainment
i) Thanks for a great weekend! We really had a/an
A) fun B) enjoyment C) hospitality D) good time
j) In order to prove Smith is guilty, we must find some
A) information B) evidence C) knowledge D) means
121
14
6 Choose the most appropriate meaning for each sentence.
a) You mustn't lose heart.

1) Don't have an operation. 2) Don't give up hope.
b) Where's my glass?
1) I need a drink. 2) I can't see.
c) Jack has a new post.
1) The postman has delivered a letter. 2) He has a different job.
d) All goods must be paid for in advance.
1) Nothing enjoyable in life is free. 2) You have to pay for these things first.
e) I've joined a new company.
1) I have a new job. 2) I have some new friends.
f) This hotel has class.
1) You can study hotel management here. 2) It is a good quality hotel.
g) I don't have the means to help you.
1) I'm not able to help. 2) I can't understand what help you need.
h) I'd like some china.
1) I want to go abroad. 2) I need some cups and plates.
i) Do you have any cash?
1) Do you only have a cheque? 2) Isn't there a place to pay in this shop?
j) They have a business in Leeds.
1) They have to go there to do a job. 2) They own a company there.
7 Complete the second sentence so that it has a similar meaning to the first
sentence, using the w o r d given. Do not change the w o r d given. You must use
between t w o and five words, including the w o r d given.
a) This island has a large population.

people
There are a lot of people on this island.
b) Do you own these things?
your
Are belongings?
c) The weather was good on our holiday.
had
We on our holiday.
d) There were a lot of cars on the road to Manchester.
traffic
There on the road to Manchester.
e) Gerry is a very strong person, in my opinion.
strength
Gerry in my opinion.
122
15
G R A M MR
A 2 1 COUNTABLE AN D UNCOUNTABLE NOUNS
f) There are pieces of paper all over the floor!

litter
There all over the floor.
g) Can I park my car here?
allowed
Is here?
h) I know these machines are very expensive.
machinery
I know very expensive.
8 Complete each sentence w i t h a suitable w o r d f r o m the box.
a) Let me give you a piece of advice.

b) There is an interesting of news in the paper.
c) A of stairs takes you to the top of the house.
d) Could I have another of paper, please?
e) Helen has a lovely of hair.
f) Do you want another of toast?
g) We bought Mike and Lynn a of cutlery for a wedding present.
h) The lightning was followed by a of thunder.
9 Complete each sentence w i t h a suitable w o r d f r o m the box.
a) I can't cut this loaf. Do you have a proper bread knife?

b) I'm afraid that 'neice' is a mistake.
c) There's usually a/an space opposite the cinema.
d) We need a/an box to keep the money in.
e) The tourist board have built a/an centre near the castle.
f) We decided to put a/an conductor on the roof.
g) Marjorie used to write a/an column in a magazine.
h) These suitcases are very heavy. We must find a/an trolley.
i) I must rush. I'm going to a/an lesson.
j) Julie found her flat through a/an agency.
123
16
10 Decide which answer (A, B, C or D) best fits each space.
Food habits
Breakfast is one of those (1) B.. that varies from person to person,
and country to country. For some (2) it means a (3)
of toast and some coffee. In various places I've also been offered
(4) or fruit. (5) executives might eat breakfast at the
(6) , while for many schoolchildren breakfast is a
(7) of milk at home, and then a long wait (8) the
first break of the morning, when they eat (9) or
(10) chocolate bar. Some families sit down and eat together
(11) the morning, and listen to (12) news on the
radio or (13) early morning television. For other people, the early
morning is a rush (14) work or school, and there just simply isn't
(15)
1) A times B meals C foods D plates

2) A people B persons C breakfasts D us
3) A sheet B loaf C slice D sandwich
4) A a cheese B the cheese C cheese D cheeses
5) A Business B A business C Business's D Businessmen
6) A train B street C morning D office
7) A glass B piece C warm D box
8) A to B is C until D which
9) A sandwich B the sandwich C a sandwiches D sandwiches
10) Aa B some C a piece D a glass of
11) A for B in C at D while
12) Aa B what C some D the
13) A look B watch C see D regard
14) A to B from C at D and
15) A there B it C enough D time
Key points 1 Check in a dictionary to be sure that a noun is countable or uncountable.

The meaning of a noun may change depending on whether it is used in a
countable or uncountable sense.
Note that some nouns ending in -5 take a singular verb:
The news is bad today
And that some nouns only have a plural form:
The police are arriving shortly. SEE ALSO
124
17
L7
Substance discovery and product development
Readthe explanationc and put the followlngwords or expressionsinto the correct column.
Research- the processof testingchemicaI withthe goalof findinga substance

compounds, which
hasa beneficial
effecton a targeteddisease.
- the processof carryingforwardscientific

Development discoveries
madeduringthe research
Research Development
$lhet klndsof R& D prdectr arethereln yourcornpanyat the noncnt?

Whichprocessiakcs longer- rerearchor dnrelopment? Why?
Whatfactorshetppharnacrutlcrl companles decidewhetdrugr they shoulddenrelop?
18
l I
18 I UNIT2 Substance andproductdevelopment

discovery
t Readthe memo and the information about filensamintil.
CaduceusPharmaceuticals
Ltd-
Date: Tuesday
To: Pharmaceutical
department- Chemistsand Pharmacologists
From: John Keyes,VicePresidentR6cD
Subiect: Breakthroughin searchfor NCE for Mensapatchrudevelopment
As someof you will alreadyknow, a new chemicalentity hasjust

beensynthesizedin our own labs,which we think may be use{ulin
our M ensaparcDrMdevelopmentplans.
A meetingwill be held tomorrow at 9.30a.m.in conference room 308

to brainstormideasfor this new substance,and to discussthe further
development.Your participationwould be appreciated.
JK
<* ME NS A MI NT T M
Mensamin{Mis a new dosagef.orm
o{ Mensad,entrM(obtainable
with physician'sprescriptiononly).
It usesthe newly synthesized
activesubsrancemensagitatum(Latin
origin: the mind moves/
animates).
The formulation for aduh patients
is in lozengeform (or as
MensadentMin chewinggum form
for young patien6), and the
indication is to stimulatebrain
activity and thinking power.
Known sideeffectsoften include
lossof sleepif takenin the late
afternoonor evening.OccasionallS
irr.rrjr. in blood pressure
may occur.Rareinstancesof heart "r,
palpitationsand headaches
havealsobeenreported.It is ,ro,
porribl. ,o orr.rdor.
mensagitatumis non-addictive. ".rd
.:*:.-+=-.:*=;.%s.+%:'l1@r
Answer the folloring questions.
r Whatis the meetingabout,andwhatneedsto be discussed?
Whatkindof productis Mensamintru?
3 Whatdo patientshaveto do to obtainit?

4 Whatarethe dosageformsof this product?
5 Arethereanyknownsideeffects?
19
UNIT2 Substance andproductdevelopmerr 19
discovery
i;:" 2
iT
An R& D meetingtakes place,in which fohn answersqu€stionsabout a new chemical
5 substance.Readhis answersbelowand write your own versionof the questions.Then listen to
the meetingand checkyour answers.l{ote: not everyquestion is askedduring the meeting.
It is already
available
in lozenge gumform,butwe hopeto develop
andchewing a time-release
oatchin the nearfuture.
Wewilt haveto testthe bioavailability

to be ableto calculate
dosagesfor non-intravenous
routes
of drugadministrationforthisNCE.
Asyouknow,whensubstances
aretakenwithatcohot or antibiotics,
theirchemicalform
could
changeandevencauseharmfulsideeffects.
I'l[keepyouinformed.
Notcompletely. However, we do havea partnerto helpus developa patchformwhichprovides

the desiredeffectsfor at leastsixhours.
I'mafraidit maytakea yearor morebeforewe canstartthe firsttestson healthvhumans.
ASKIl{GABOUTDRUGDISCOVERY
A1{DDEVELOP'IiEl{T
Dosage Development
Whatkindof formulationcouldwe devetop? Whatis thetoxicityof this NCE?
Whataboutusingotherforms? W hataboutthe bi oavai tabi lof
i tythi sN C E ?
or dropspossible?
Aretablets,capsules, Whencanwe startthe firstin-manstudy?
Whataboutthe dosagefor theseforms? Dowe havethe technology to makepatches?
20
20 | UNIT2 Substance andproductdevelopment
discovery
3 Putthe correctformof oneof thevocabulary

ltemsfromthe boxintothe sentences
below.
chemisto dosage
fo-rm. formulation. in-manstudy r prescription
. toxicology
r A specialist
or expertin thescientific
fietdof chemistry
is calleda . Inthe UK,
thiswordis alsousedfor the personwhoprepares

andsellsmedicine,
alsoknownas a
in the US.
oharmacist
z Usingthe right is especially whengivingmedicine

important to children,
theyoftenhaveproblems
because pills.
swallowing
of poisons,
3 Thescience including
theirsource,
chemicaI
composition,
action,tests,andeventheir
antidotes,
is whatwe call
4 lf a drugor medicine
is notavailable
'over-the-counter',
it normally
meansthata
froma physician
is neededto obtainit froma pharmacy.
andpharmacologists
5 Chemists arealsointerested
in howthe medicine
is administered,
so they
oftenaskaboutits
5 Beforedrugsor medicines to the public,theyhaveto be testedon human

canbe madeavailabte
beings.
Wecallthisan . lt is alsocalleda phaser, stager study,or ctinical
triat.
4 A fewdayslater,the participantsreceivedthe minutesof the meeting.Listenagainto exercisez

andput the paragraphsin the correctorder.
Minutes of Tuesday'sbrainstormingmeeting
participants.He also
The Vicepresrdentof R&D beganthe meetingon time and welcomedall the
wasout of town and wasnot ableto attend'
mentionedthat Derekfrom Pharmacokinetics
A I Finalty,Brian askedif the new dosageform could be madewith current technology'
e I Next, therewassomediscussionabout the time frame necessary for in-man studies'
C l) fhen Marcus brought up the subjectof the NCE's toxicity'

NCE'
OI Hlaa initially askedwhat kind of formulation could be developedfrom the new
t I ,Lfter that, Frank askedabout the bioavailabilityof the new chemicalentity.
The meetingfinishedat 10.30a.m.The next PHARilACOKI

1{ETICS
V5. PHA,RTIACOI-OGY
includingDerek,
meetingfor all participants,
Pharmacology is the studyof drugs,howthey
will take placein one week.We will then decide
work,andwhattheydo in the body.
how to proceed.
Pharmacologycanbe dividedintotwo separate
areas:pharmacodynami cspharmacoki netics
and
Pharmacodynamics studieswhatthe drugdoesto
the body,andpharmacokinetics studieswhatthe
bodydoesto the drug.
21
UNIT2 Substance andproductdevelopment ZL
discovery
AUOtO
g\ 5 fanet, a chemist,and Brian,a pharmacologist,meet to talk about the brainstormingmeeting.
w listen and decideif the statementsa]e tsue(r'\or false (I).
6
r fJ fhe side-effects for the productis not finishedyet.

research
z [_l Thereareotherdosageformswhichworkbetterthanthe patchform.
3 n lt witlontytakea few monthsto furtherdevelopthe patchform.
4 [ Cream,
ointment,
andsuppository for thisproduct.
formswouldalsobe possible
S f] to maketabletsand pills.
fhe companyalreadyhasthe technology
; Wewitlneeda bit moretimeto completely answerthatquestion.

I Weare stillrunningfesfsto find out what kindsof sideeffectsare possible.
Wecangiveyou the answerin oboutfour weeks.
lt will takefrom obout sixmonthsto o yearand o half.
Notyet! But we?eworkingon it.
6 Putthewordsin the right ordertb makequestionsandanswersaboutsubstance

discovery.
I formulation
Question kindwe Whatof developcould?
Answer
t yet, know on We we're it don't but working
z about forms What the. dosage?

Question
Answerz answeryet don't haveWe a completeto questionthat
3 NCEthis is What toxicityof the ?

Question
j
Answer about give the four can We weeksyou answerin
4 can study the Whenwe in-manstart first ?

Question
Answer
4 six year and a half We from need to monthswill a
Question5are What effectskinds possibleof side ?
Answer
5 to stitl tests We runningfind are out
22
productdevelopment
22 | UNIT2 Substancediscoveryand
Talk about a drug in researchat your company.llention the following points:
developmentperiod o dosageform o studyresults . toxicity
7 natci the words from the box with the pictures,and fitl in the gaps in the fotlowing text with the
correct dosageform.
dosager drops r patcho pitls. suppository. syrup.rtablets
7 the correct
Calculating for somepatientsisn'talwayseasy.
2 Childrenandolderpeopleoftenhavetroubleswallowing
large
3 Wearinga maycreateproblemsfor peoplewith skinallergies.
4 Somemedications in liquidform,suchas
areavailable or
5 Weoftenusea to administer to babiesor otheroatientswho are

medication
not ableto takedrugsorally.
23
UNIT2 Substance andproductdevelopment A
discovery
;: I Helenfromtarketing Research callsfohn,YicePresidentof R& D,to discussthe resultsof a

t hospitatIn-patlentsuryeyon dosageformsfor a nw medication.Thecompanyneedsto knor
whlchdrugdosageformspatientsprefer.Llrtento the telephonecatl andfi1l in the formbelo;.
Hospital In-patient DosageForm SurveyResults
I . Total number of in-hospital patients surveyed(a)
2. Male patients(b) Femalepatients (c)
3. Averagepatient age(d)
4. Which of the followin g oral dosageforms are the p atients currently losing?
tablet (e) gel tablet (f) _ capsule(g) _ pill (h)

solution drops syruP other(s)
5. Which of the following dosageform(s) do the patients favour?

oral dosageforms
tablet geltablet (i) _ capsule(j) _ pill 8Vo
solution drops (k) syrup(l) other(s)
inhaled dosageforms
aerosol(nr) inhaler other(s)
topical dosage forms
cream (n) ointment (o) liniment lotion
gel other(s)
other dosage forms

nasal spray eye drops +) suppository_
6. What kinds of side effectsdid the patients have with their current medication?
The following side effectswere experienced:
allergic reaclions 791 diarrhoea 29 dizziness 3

fever 7S headache 91 indigestion 122
insomnia 17 itching 70 nausea 253

skin rashes tg vomiting 17 other(s)
7. Do the patients have any suggestionsfor other future forms of medication?

List all suggestionshere:
8. Do the patientshaveanyof the followingchronichealthconditions?
asthma 791 anaemia 121 bronchitis ,r5 diabetes 83 heartcondition 21
..'
"#*F+s 'ru*"us--.,','.,',@*r!s:-::, . :,+.*-ss::=+.#' "'_ " -
24
24 i UNIT2 andproductdevelopment
discovery
Substance
9 Answerthe following guestionsusing the informationin exercise8.
r Howmanypatientsweresurveyed
in a[[?
2 Weremoremateor femalepatients
interviewed?
by the patientssurveyed?
3 Whatkindof dosageformis mostpreferred
4 Whatkindsof sideeffects by the leastnumberof patients?

wereexperienced
did mostpatients
5 Whatchronichealthconditions have?
tO f,latchthe dosageform on the teft to its definition on the right.
1 ' _ aerosol a A verysmallamountof liquidthatformsa roundshape.
2 , . drops b An smooth,thicksubstance
to rubon theskinfor healing.
3 '-' inhaler c An oilytiquidto rubon painfulbodypartsto reducepain.
4 .. liniment d A medication or clothplacedon theskin.

on material
-
5 , ointment e A smal[,roundpieceof medicine
to be swallowed
withoutchewing.
-
6 patch f A container
witha tiquidthatis administered
in sprayform.
Ti pil g A liquidin whichanothersubstance

hasbeendissolved.
8 I ; solution h A solidmedicine
whichmeltsslowlyin the rectumor vagina.
glr suppository i A sweet,liquidmedicine

takenwitha spoonor cup.
10 i_:l syrup I A smalldevice

withmedicine in throughthe mouth.
to breathe
25
U N I T 2 S u b s t a n c e d i s c o v e r yparnodd u c t d e v e l o p m e n2t 5
ASK|l{GFORAt{DGlVt!16OHmOTS
Askingfor opinions Avoiding/Withhold ing opinions

W hatdo y out h i n k ...? I wouldrathernot say...
What'syouropinionon ...? I'msorry| cannotcommenton ...
What'syourviewof ...? I'mafraidI am not in a positionto answerthat.
Givingopinions Givingstrongopinions
I t hink / lf eel. .. | firmtybelieve...
I n m yopinion... , I feelverystronglythat ...
Frommy pointof view,... I'msure/certain/convinced ...
7l Rephrasethe fotlowing statementsfor conductingor taking part in a survey.Usethe Useful

Phrasesabove.
to cureheartdisease.(Askfor opinion)
1 A newdrughasrecentlybeendeveloped
pill,and patch.(Askfor opinion)

z Morethanonedosageformis beingconsidered:
3 Thein-manstudiesforthisdrugwilltakemorethansixmonths.(Giveopinion)
4 Additional (Giveopinion)
shouldbe donein othercountries.
clinicaltrials
5 Thisnewformulation (Givestrongopinion)
will be successfut.
nasalspray.(Givestrongopinion)
6 A thirddosageformshouldbe devetoped:
7 Youdon'thaveenoughinformation (Avoidopinion)
to makea statement.
you haveyet.(Avoidopinion)
8 Youdon'twantto sharethe information
What kind of medicationis often taken on a regular basis,and in what form?

Whichside effectsdo you feel peopledistike the most?
Doyou preferto take medicationin a particularform? lf so, which form, and why?
t2 Twoscientists meet to discussthe developmentof an l{CEand its possiblefuture

formulation(s).Theydiscussand give their opinionson dosage,development,and time periods.
Par tnerA F i te 2, p.76

Par tner B F i l e 2. p.78
26
26 | UNIT2 Substance andproductdevelopment
discovery
Readthe article below about different classesof drugs in different countries.
Howmany drug categoriesdo we need?

1f'\ n the whote,countries estabtish specific At present, the FoodandDrugAdministration
V rutesandregutations notontyonthetype is reviewing its currentpoticyonthe number of
of drugsmadeavaitable, but atsoon howthey categories. It is discussing the introduction of
reachtheconsumer. 0n theonehand,medicine a newintermediate category for the USmarket
needs to beeasityaccessibte. Thisis, of course, catled'behind-the-counter' (BTC)medicine.
a question of pubtichealth.0n theotherhand, Drugs of this typewouldneedno prescription,
thesesameproductscan do harmif used but woutdrequirea pharmacisfs intervention
incorrectly.Thisdangermustbeavoided. andresemble category 2)in Canada. Onereason
Forthis reason,regulatory authoritiesin is that consumers in manyWestern countries
everycountrysetthe number of categoriesfor havefoundthis newcategory beneficiat.
drugs.Forexampte, in Canada, therearefour: In Europe, the conceptof BTChas been
1) drugsavaitab[e onlywitha prescription practised with greatsuccess for years.Peopte
2) thosewithouta prescription, but ontywith canjustgoto their[oca|. pharmacy anddescribe
the personaI involvement of a pharmacist their medicalneed.The pharmacist simply
3) medicine whichcustomers canpickoff open recommends an appropriate drugwithoutfirst
shelves, but onlyin a pharmacy, and requiring a docto/sprescription. Heor shecan
4) products whichcanbe opentysoldin any atsosuggest a lessexpensive drugin generic
kindof retailouttet. form. The disadvantage, however, for many
By contrast,the US onty has two fficiat Europeans is that the costof thesedrugsor
categories: drugsneedinga prescription and medications is not takenon by the heatth
drugsthat do not.Theformerareprescription insunncesystem.
drugsandareavaitabte in pharmacies andonty Currentty, the FDAis facedwith a difficutt
byprescription. Thelatterareover-the-counter decision. If it decides to addthe category BTC,
drugswhichcanbe sotdin anytype of retail this wi[[ havedefiniteconsequences for the
outletthat chooses to stockthem. pharmaceutical industryin the US.In theshort
In generat,in the U5,medication mustmeet term,this change wouldimmediately forcethe
fourcriteriain orderto obtainthe statusof a pharmaceutical companies to reorganize their
non-prescription or over-the-counter (0TC) marketing efforts.In the [ongterm,companies
product. It musthave: andresearch instituteswoutdneedto reassess
- a largemarginof safety theirownpotentia[ andreconsider whichtype
- lowincidence of sideeffects of drugsareworthtesting. I
- lowpotentiatfor misuse andabuse, and
- Labetting that provides adequate directions
for sateandeffectiveuse.
72
@
e Whatarethe advantages of providingdrugsand medications
by prescription,
BTC,andOTC?
. Howaredrugsandmedications madeavailable in yourcountry?
. Whichmethod(s) do you prefer?
. Shouldpatientshavethe rightto obtaindrugsandmedication onlinefromothercountries?
27
GRAMMAR 22 ARTICLES
Put a/an or the in each space, or leave the space blank.
a) We went by /.. - train to the west of England.

b) people who live in Netherlands are called
Dutch.
c) judge sent me to prison for ten
years.
d) Columbus was one of first people to cross
Atlantic.
e) As captain of ship, I have
complete authority.
f) David learned to play violin when he was at
university.
g) Trafalgar Square is near Charing Cross Station.
h) Did you read book I lent you last week?
i) We'll put up shelves and then go to cafe for
something to eat.
j) Is that present Bill gave you for Christmas?
2 Underline the most suitable phrase in each sentence.
a) Is this a person/the person you told me about?

b) This is the only cinema/an only cinema in the area.
c) Philip has just bought the Thames barge/a Thames barge.
d) I'm going to the British Museum/British Museum this afternoon.
e) Are you going to church/the church on Sunday?
f) Do you have a milk jug/milk jug?
g) The Prime Minister/Prime Minister will give a speech this afternoon.
h) The computer/Computer has already changed our lives dramatically.
i) I haven't been to an open-air theatre/open-air theatre before.
j) Here is a thousand pounds/the thousand pounds I owe you.
127
28
a) The butler was .C I suspected.

A) last person B) a last person C) the last person D) some last person
b) Where you borrowed last week?
A) is scissors B) are the scissors C) is some scissors D) are scissors
c) Why don't we go to the park ?
A) in the car B) with a car C) with car D) by the car
d) Too much rubbish is being dumped in
A) sea B) the sea C) a sea D) some sea
e) This is exactly I was looking for.
A) job B) a job C) some job D) the job
f) Of all these cars, I think I prefer
A) a Japanese B) some Japanese C) the Japanese one D) a Japanese one
g) I try to go jogging at least four times
A) the week B) of the week C) a week D) of a week
h) Sally spent six months out of
A) work B) a work C) the work D) some work
4 Complete each sentence (a-i) w i t h one of the endings from 1-9. More than one
answer may be possible.
a) Some people say that the 9.

b) Most people think that a/an
c) I don't agree that
d) I feel that a
e) I don't believe that a/an
f) I didn't realise that the
g) It's incredible to think that a/an
h) I didn't know that
i) I think it's quite unfair that the
1 good job is an important part of life.

2 single injection can protect you from so many diseases.
3 hundred miles an hour is too fast even on a motorway.
4 the unemployed should receive more help from the state.
5 queen of England doesn't pay any income tax.
6 tiger may well become extinct very soon.
7 third of a person's income should be paid in tax.
8 English are difficult to get to know at first.
9 the Tower of London was built by William the Conqueror.
128
29
GRAMMAR 22 ARTICLES
5 Put a/an or the in each space, or leave the space blank.
a) Neil Armstrong made ...the first footprint on the Moon.

b) There was accident yesterday at corner of
street.
c) I need time to think about offer you made me.
d) recipe for success is hard work.
e) people who live in glass houses shouldn't throw
stones.
f) worst part of living in a caravan is
lack of space.
g) book you ordered last week is now in
stock.
h) dancing is more interesting activity than
reading.
i) people we met on holiday in
north of England sent us postcard.
j) little knowledge is dangerous thing.
129
30
a) There is one problem here, and that's the weather.

only
The only problem here is the weather.
b) There are no good films on this week.
cinema
There is nothing this week.
c) Can't you swim faster than that?
fastest
Is can swim?
d) I haven't been here before.
time
This is been here.
e) A lot of wine is drunk in France.
French
The a lot of wine.
f) If you drive faster, it is more dangerous.
the
The dangerous it is.
g) It is difficult to discover what is true.
truth
The discover.
h) Are you a good pianist?
piano
Can you well?
7 Underline the most suitable phrase in each sentence.
a) I was under an impression/under the impression that you had left.

b) I have to go. I'm in a hurry/in hurry,
c) I managed to sell the old painting at a profit/at profit.
d) I think I prefer the other restaurant on the whole/on whole.
e) How many hours do you work, on average/on the average, every week?
f) I was in pain/in a pain after I twisted my ankle.
g) Jack recovered from his accident and is now out of danger/out of the danger.
h) Excuse me, but you're in the way/in a way.
i) Sue felt seasick on the cross-channel ferry/a cross the channel ferry.
j) The burglar hit me on my back of the neck/the back of my neck.
130
31
Quality assuranceand auditing
Readthe definition of 'good practice',then matchthe wordswith the correctabbreviations.
for'good practice''
GxP is an abbreviation
The 'x' is used to indicate the manY
differentareasof 'goodpractice'which
arerequiredby internationalregulatory
authorities'
GABGCBGDRGLB auditing r clinical o documentationo laboratory

GMBGRBGSP r manufacturingo researcho safety
tt's good practice.
r Whichof theseformsof goodpracticeareyoufamiliarwith?

. Canyou giveexamplesof goodpracticerequirementsusedin yourcompany?
32
28 | UNIT3 Qualityassurance
andauditing
BernerPharmaceuticalsltd providesemployeeswith generalinformationon GMPon its

intranet. Readthe following text and answerthe questions.
Password:
In the pharmaceutical
industry,differentqualltyassuranceprocessesare requiredfor
eachareaof good practice
(GxP).
It is easiestto understandhowgoodpracticeworksin the areaof manufacturing. The
qualityassuranceprocessin goodmanufacturing practice(GMP)includesproductquallty
control,sampling, andtesting.Qualitycontrolensuresthat the productqualityremains
high.Thereasonfor interimtesting,or productsampling,is to checkthe qualityof
pharmaceutical products.Thisis importantto makesurethat the productis sultablefor
its intendeduse and for sale.Endpointtesting is carriedout at the end of every
manufacturing process.This is to ensurethat all procedureshavebeenperformedin
compliance withindustryandcompany standards.
Documentation is importantand necessaryqt everystep of the processes,activities,and
operationsinvolvedin drugmanufactuflng. lf the documentation
is not in order,or if the
requiredspecificationsare not met,then the productis consideredcontaminated.Proper
documentation not onlyenablestraceablllty,but also allowsa completeproductrecall
fromthe market,if necessary.
Inspectionand validationare requiredto provethat the manufacturingand testing
equipmentis functional.All operationalmethodsand procedures must also be inspected
for accuracy.
Mostcompaniesdo this voluntarily throughinternalaudit processes.
However,beyondthe fieldof manufacturing, goodpracticemust be adheredto in all
processesin a pharmaceutical
company.No processcan be consideredisolatedfromthe
others.Forexample,laboratoryand manufacturing processescannotbe regarded
separately.
A holistlcapproachlooksat all theseenvironmentsto makesurethat the
entireprocessmeetshighindustrystandards.
Standardoperatingprocedures (SOPs)are writtenand usedby companiesto makei{
easierfor them to followGxPTheseare a set of writteninstructionsto maintain
performance and results.Theyare alsothe basisof everygoodqualityassuranceand
qualitycontrolsystem.
33
UNIT3 Qualityassurance
andauditing 29
Accordingto the text, which answeris not correct?
r Whyis productsampling carried

out?
a Tointroduceproductquatity.
b Tocheckproductquality.
c TomakesureSOPsarefollowed.
d Tomeethighindustry standards.
z Whichaspectof drugmanufacturing
enables
traceability?
a qualityassurance
b qualitycontrol
c holisticapproach
d documentation
3 Whydo operationalmethods andprocedures haveto bevalidated?

a Tocomplete thequalityassurance process.
b Tomakesureproducts perform
theirintendedfunction.
c Tocomplete theinspectionprocess.
d Toisolateproductsof highquatity.
2 Gompletethe following sentenceswith the correctword or expressionin bold from the text in
exercisel
r Thedocumentation
required processes
for all research anddevelopment
stepsensures
the
of a drug.
zA considers
[aboratory processes
andmanufacturing andenvironments
andnotindividually.
together
I Quatity involves processes

all manufacturing in GMPwhichmakesurethe
goodsproduced
arekeptat highstandards.
4 Quality interimandproductsampling
invotves procedures,
whicharecarried
outto checkproductquatity.
5 At the endof everystageof a product'smanufacturing

process, is doneto
quatitystandards.
maintain
6 Evena productthat hasbeenmarketedfor yearsmighthaveto be takenoff the marketin a
if seriousadversereactions
occur.
processes
7 Manufacturing andprocedures
mustgo throughperiodic to
guarantee
thattheyarestillofan acceptable
standard.
products
areno longerpureandacceptable
for saleor publicuseand,
mustbe returnedto the manufacturer,

therefore, or destroyed.
34
30l UNIT3 Qualityassurance
andauditing
3 ln order to complywith the internal audit requirementsfor GoodLaboratoryPractice(GtP) of

the EuropeanMedicinesAgency(EMEA)for pharmaceutical firms,BernerPharmaceuticalsltd
needsto completean audit of their current laboratorysafety systemsand procedures.Readthe
mem.ofrom the Quality AssuranceInternal Auditing Departmentand answerthe questions.
- InterofficeMemorandum-
Date: Monday
To: Philip Reuter,LaboratoryManagement
From: josephMason,Quality AssuranceIntemal Auditing
Subject: Annual audit of SOPsfor laboratorysafety

Auditor
Cc: RichardJacobs,SeniorQuality Auditor; Gail Webber Operations
(see 86)
Attachment: Audit checHi.*tfor laboratorysysternsand procedures P'
has been scheduledfor a periodic audit of the

This memo is to adviseyou that your department
laboratory safetysystemsand procedures'
as follows:
The timetable for the various laboratory audits is
Laboratory l: Tuesdayand Wednesday

Laboratory 2: Wednesdayand Thursday
Laboratory 3: ThursdaYand FridaY
with
pleasemake sure that all the laboratory staffare advised and prepared in accordance
team (Richard Jacobsand Gail webber)
standard audit procedure. Two members of our audit
on Tuesday,two weeks from tomorrow, using the latest comPany-
will begin this internal audit
approved audit checklist (seeattachment)'
will be reviewed with you and the Research
The completed checklist and original audit results
andDevelopmentVicePresident.ourgoalistoidentifyanyareasrlcuiin'scorrectiveor
done
preventive action before o r*r*-u.y..port of the statusof theseactions is issued'This is
especiallyfor safetyprocedures'
,o compliance with industry standards'
"rro..
with regard
pleaseconfirm receipt ofthis memo and send us a copy ofall your correspondence
to this scheduledaudit.
J. Mason
Whatkindof internalaudithasbeenscheduled?
Whatis the objective

of thisaudit?
3 Howoftendoesthistypeof audithaveto be done?
4 Whenwilltheaudittakeplace?
5 Whatdocumentation
is necessarV
for theaudit?
35
UNlT3 andauditing 31
Qualityassurance
Doesyourcompany alsohaveplanned or scheduled

audits?lf so,forwhichareasandhowoften
aretheycarriedout?
a Haveyou everbeenpartof an internalaudit?Whatdid you do?
a Whatkindof specialprocedure(s)
doesyourcompanyfo[[owfor internalaudits?
CAPA
Action/Preventive
Corrective Action(CAPA) is a part of the overal[QualityManagement System(QMS)
requiredfor GMP.lt focuseson the systematic investigation of non-conformance events(errorsor
deviations),to preventtheiroccurrence(forpreventive (forcorrective
action)or recurrence action).
usEFuLPHBASiS-
- il{foRmmG
This...is to advise...that ... The...is as follows:...
The...wittbe reviewed ... Pleasemakesurethat ...
Ourgoalis to ... Pleasesendus...
...department is scheduled for... Pleasetonfirm...
4 Match the tasks on the left with the phraseson the right.
rI Youstatethe reasonfor a memo. a Please

sendus...
zI Youstatethe objectiveofa course b Thismemois to adviseyouthat...

of action.
3[ Yousaythe planned
schedule. c Ourgoalis to ...
4n Youaskfor verification
of some procedures
d Thelaboratory will be
information. reviewed...
5il Youneedto havea copyofsomething. e Pleaseconfirm...
6fl Yousaywhichdepartment
in the f Please
makesurethat...
companyis involved.
u
7n
::' " "'''
Yousaywhatareaswiltbe audited.
ff.:1,ffi1'.'J,'Ji,l
8I Yousaywhatshouldbe done. Thetimetableis as follows...
36
32 | UNlT3 Quatityassurance
andauditing
5 Complete the memoto yourownstaff.Letthemknowaboutan upcoming

audit.Usethe Useful
Phrasesfrompage3r.
(your company)
- Interoffice Memorandum -
Date:
To:
From:
Subject:
Cc:
Attachment:
This memo I that your department has been scheduledfor a periodic
audit oflaboratory safety systems and procedurqq,
The timetable for the various laboratory audits is as follows:
Building l: Tuesdayand Wednesday

Building 2: Wednesdayand Thursday
2 that all the employees

3re informed and prepared in accordance with
standard audit procedure. Two members of our audit team (

(nmes)
will carry out this internal audit from to _, using the latest company-
(dat€) (date)
approved audit checklist.
The completed checklist and original audit results I with you and the Director
ofLaboratory Management,to identifr areasrequiring corrective or preventive action before a report of
the statusof thesecorrective or preventive actions is issued. 1is to identifr and
correct any quality system defects and to assurecompliance with industry standards, especially for
laboratory procedures.
5 receipt of this memo and 6 a copy ofall your
correspondence with regard to this scheduled audit.
37
UNIT3 Qualityassurance
andaudrting 3
H6
Itt
Listento a laboratorystalt meetlngin whichpreparationsfor an intemal audit of laboratory
8 safetyprocedurcs arediscuss€d. Arethe statementsVue(r') or false(,x)?
r I fnis is a plannedaudit.
z I fhe auditorswill be givinginformation

to the
labtechniciansduringtheaudit.
3 [ Oneof the tabtechnicians

willbein London
duringtheaudit.
a I Thelaboratory staffwillontybe cleaning

the
to preparefor the audit.
laboratories
5 [ Thejuniorlabtechnicians
willbe cleaning
the
laboratoriesandchecking
the workstation
equipment lists.
7 Complatethe sentenceswlth words from the bor.

\
safety"r short r updated. upto,date
checklist. finding. non-compliancerr',observt|,i
1 Advance
noticeof this meetingwasvery
2 procedures
makesurethatthe healthandwell-being
of laboratory
workersareguaranteed.
3 Auditorsgenerally
watchor safetyprocedures
in the lab.
workersareaskedcertainquestionsaboutsafetyprocedures,
4 Toensurethat laboratory auditors
usea
5 lf any is observedduringthe audit,the department

will be informed
so theycantakecorrective
action.
operatingprocedures
6 Standard (SOPs)
are on a regularbasis,often
afteran audithasbeencarriedout.
oftenreadjournalsandgo to international
7 Scientists conferences,
because
theyneedto stay
in theirscientific
fields.
8 Anyobservation
or notedby the auditorsis categorized
as either
maior,minor,or critical.
38
34 I UNIT3 Qualityassurance
andauditing
8 Whatkindsof questionsaboutlaboratorysafetysystemsandprocedures
might beaskeddurlng
|
' an internalaudlt procedure?
Writedownexamplesfromyour owncompany.
lii
YY'
9 Listento a conversationbetweenan asditorandtwo tabtechniciansduringan audit of safety
i proceduresin a laboratory, and answer the questions.
r Whatdepartment from,andwhatis herjob?

is GailWebber
z Whatmustbe doneif non-comptiance

is observed?
3 WhatareCharlie's job titles?

andJennifer's
4 Namesomeitemsof protective
clothingthat mustbe wornin the laboratory.
ASK|r{GQUESTTOI{S
DURilGA1{AUDTT
Talkingtostaff
Whatis yourname?
Whatis youriob?
Whatis yoursupervisor's
name?
job?
Whatis yoursupervisor's
Asking about processesand procedures

Howhaveyou beentrainedto performthis procedure?
Howmuchtimedoesit taketo complete this partof the process?
Whatspecialprocedures mustbe followedin a laboratory?
Whatspecialprocedures mustbe followedfor this process?
Askingaboutpossibleactionstaken
Howdo you handletoxicwastein the lab?
Howdo you handlethe transportationof animalsin the lab?
Whatwouldyoudo if yougot a toxicsubstanceon yourlabcoat?
Whatwouldyoudo if you noticednon-compliance with safetyprocedures
by a colleague?
39
U N I T 3 Q u a l i t ya s s u r a n caen oa L c : - g 35
10 Practiseasking and answeringaudit guestionswith a partner. Usethe laboratoryclothing and

equipmentfrom the list belowand the U*ful PhrasesoRFage34.
. eyebath
. gasmask
r hairnet
. laboratorycoat
r latexgloves
. overshoes
o safetyglasses/goggles
r safetVgloves
. binsfor toxicsubstances
1l Readpart of the internal audit report doneon the three laboratoriesat EernerPharmaceuticals.
Thereare ftve non-complianceareas which were observedby auditors facobs and Webkr.
Berner Pharmaceuticals Ltd Internal Audit Report - Friday13

June2010
Purposeand Annual audit of safetyprocedures
in all laboratories
areadescription:
Major facts: Although there were no serious instancesof non-compliance,

a number of
incidents of undesirableconditions and practiceswere observed.
These need
to be corrected before the follow-up review in 30 days.
Observations: a) Six laboratory techrricianswore unsuitable clothing and safety

equipment.
b) one lab assisiantdid not wash her hands after a procedure
involving mice.
c) Times of the experimentswere not entered on two of the
daily lab reports.
d) Mice were transported in open cages(in public) to a second
lab.
e) Improper disposal of toxic waste material was recorded.
Follow-up: A review of the proceduresin Labs |, 2, and 3 will be carried

out . . .
l{ow matchthe areasof non-compliancefound by the euditors with their obsarvations.
Non-compliance
areas Auditors'observations
r ,-, improper
clothing/safety
equipment d foundin normalwastebins
chemicals
z i - improper
hygiene
afterhandling
animals b labmicemovedoutdoorsin opencages
3 i ; improperdocumentation c safetyglovestoo big,no safetygoggles
4 i , improper
transportation
of labanimals o no recording times
of experiment
S i-l improper
disposal
of toxicwaste hand-washing forgotten
or sanitizing
40
36 I UNIT3 Qualityassurance
andauditing
SUGGESTIl{G
CORRECTlVE
ACTIOl{
Neutral Strong
I suggestyou put 'Notoxicwaste'onthe bin. Theonlysolutionis to rethinkthe process.
My suggestion is thatwe redothe equipmentlist. I stronglysuggestthatwe try to preventit in future.
My.recommendation is to talk to the lab workers. I'mconvinced we mustrepeatthe lasttests.
It mightbe possibleto relocatethe equipment. It is absolutely to learnthe safetyrules.
essential
t2 Write five suggestions for corrective action to solve the safety problems in the Berner
Pharmaceuticalslabs (see exercisefl). Usethe Useful Phrasesabove.
tj on laboratoryprocedures.
ReadercerptsfromBernerPharmaceuticds'SOP Thenmatchthemto
warningsignsa-e.
@
Always use
cages to
lab animals!
rI mustbe disposedof properly.

Al[toxicwastematerials
z i) Goodsanitaryhygienemustbe practised
by all labstaff.
3T Protective
clothingmustbe wornin the labsat alltimes.
4n Labanimalsmustbe transported
in coveredcages.
5n Eyeprotection
mustbe wornas signposted.
41
UNlT3 andauditing 37
assurance
Quality
soPs- PRocEssEs,
Dtscusslt{G PRocEDuREs,
DocutEl{TATtolt,
TtmlilG
Requestinginformation
Pleasedescribe for the ...process.
the procedure
Wouldyou pleaseclarifyhowyou ...?
Couldyouexplainthe procedurefor the documentation
of ...?
Askingquestions
Whatarethe guidelines
for...?
Howoftendo you haveto ...?
Whatspecialproceduresdo youfollowfor ...?
Howwould you ensuregood hygienein the laboratory?
FormulatingSOPguidelines
Properprotective
clothingandsafetyequipment mustbe wornat all times.
Propersafetyproceduresmustbe carriedouf by laboratorystaff.
Toxicor hazardousmaterialsmustbe disposedof properly.
mustor shouldbe +verb.
Note:SOPsoftenusethe followingstructure:
t4 FormulateSOPguidetines.Conyertthe following sentences.
Example: UsesafetySOPsfor workingwith laboratory animals.

SafetySOPsmust be usedfor working with laboratoryanimals.
r Performa[]workwithvirus-infected
animalsin the bio-safety
cabinet.
z Usedisinfectant
on equipmentfollowinganyexperiments
with [aboratory
animals.
in the laboratory
3 Wipeup allchemicalspitls immediately.
gownsor labcoats,latexgloves,andsafetyglassesat alltimes.

4 Wear[aboratory
agentspitlswith a papertowelandtreatthemwith bleach.

5 Coversmallbiological
all laboratorv
6 Document workin accordance
with GLP.
75 An internalauditoranda laboratorytechnicianmeetto discussthe standardoperat:ng

proceduresfor safetyin the laboratory.
42
38 i UNIT3 Qualityassurance
andauditing
Readthe foltowing newspap€rarficle.
Drugcontamination:lessonsto be tearned?
A fewyearsago,a wett-known European pharmaceutical
company wasforcedto recatlone
of its drugsdueto claimsof productcontamination. Therecalltook ptacefollowingreports
frompatientsthat theirmedication hada strangeodour.Severalpatientsfroma numberof
differentcountriesmadethe comptaintwithin a shortperiodof time.A few patients
experienced nauseaimmediately aftertakingthe medication.
Unfortunatety, the drug
manufacturer wasunab[eto sayjusthowmanypatientsweretakingthis drugat the time.
However, it estimatedthe gtobalfigureat over40,000people.
Immediate investigations
showed that samptesof the tabtetscontained
abnormally
highlevetsof a harmfulgenotoxicsubstance.Thecontamination wastracedbackto its
manufacturing ptant.According
to reports,
it seems that an unanticipated
reaction
between
the drug'sactiveingredient
andthe chemicats usedas partof the cteaning
processes
at the
sitewasthe causeof the contamination.
Thecompany ctaimsthat a cteaningerrorwasthe reason for the entireincident.Thisctearty
undertines the dangerof underestimating the igrportanceof the cteaning process in
pharmaceutical manufacturing.Vatidatidil
of cteaning processes is essentiaI
in this industry,
because chemical or bacterialcontamination of drugproducts canpotentiaU.y Leadto severe
pubticheatthrisks.Regulatory bodies,suchasthe USFoodandDrugAdministration (FDA)
andthe European Medicines Agency (EMEA), require
validation of cteaningprocesses. In
fact,if thereis evidence that a company is tryingto savemoneyby reducing theircleaning
activities,theseagencies takeaction.
In the abovecase,no otherproducts manufactured by the pharmaceutical
companywere
affectedby the mistakeandthe contamination errorwasquicktyrectified.However,
the
itl patientswithoutpropermedicine.
recallleft seriousty TheWorLdHeatth0rganization
recommended that patientstry to find a suitabteatternative.
@[
. Whatroledid pharmaceuticaI
manufacturing processesplayin thisincident?
. Howcouldthecompany haveavoidedthisrecal[?
Consider the roleof qualityassurance,
quality
contro[,
audits,andinspgctions.
r Whateffectdo productrecal]s
haveon a pharmaceuticalcompany?
o Hasyourcompany everbeeninvolvedin a productrecall?
43
GRAMMAR 24 MAKING COMPARISONS
Put one suitable w o r d in each space.
a) My brother is two years older than me.

b) The train takes just long as the bus.
c) I thought the second hotel we stayed in was more friendly.
d) Unfortunately we are well-off than we used to be.
e) Do you think you could make a less noise?
f) These exercises seem to be getting harder and
g) Jean doesn't need as much help as Harry
h) David didn't enjoy the match as much as I
2 Rewrite each sentence beginning as shown. Do not change the meaning.
a) Jill can run raster than Peter.

Peter can't run as fast as Jill (can).
b) I thought this journey would last longer than it did.
This journey didn't
c) I didn't arrive as early as I expected.
I arrived
d) You are working too slowly.
You'll have to
e) I have a brother who is older than me.
I have an
f) Martin thought the second part of the film was more interesting.
Martin didn't think the first
g) Paula's work is less careful than before.
Paula has been working
h) There aren't any trains earlier than this one.
This is
i) All other cafes are further away.
This cafe
j) Is this the best price you can offer?
Can't you
141
44
FIRST CERTIFICATE LANGUAGE PRACTICE
a) I really think that apologising is C. you can do.

A) not as much as B) a little C) the least D) as far as
b) I can't stand this weather. It's getting
A) more and more B) worse and worse C) coldest and coldest
D) further and further
c) Although Brenda came last, everyone agreed she had her best.
A) done B) made C) had D) got
d) I wish Charles worked as hard as Mary
A) did B) can C) will D) does
e) The more you water this plant, the it will grow.
A) best B) tall C) wetter D) faster
f) From now on, we won't be able to go out as much as we
A) were B) had C) used to D) will
g) I've never owned independent cat as this one!
A) a more than B) such an C) a so D) as much an
h) Brian has been working since he was promoted.
A) much harder B) as harder C) just as hardly D) more hardly
i) I've been feeling tired lately, doctor.
A) such a B) the most C) more and more D) much
j) This exercise will give you practice.
A) farther B) much more C) as better D) a lot
4 Put one suitable w o r d in each space, beginning with the letter given.
a) Is William feeling any better. today?

b) Everyone ate a lot, but Chris ate the m
c) What's the 1 news about the situation in India?
d) I'd feel a lot h if you let me help.
e) Graham has been sinking d into debt lately.
f) It's 35 degrees today! It must be the h day so far this year.
g) Only £45? Is that all? Oh well, it's b than nothing.
h) He had to wait a f two months before he got his promotion.
i) Ruth wore her b dress to her sister's wedding.
j) Harry has got over the w of his cold.
142
45
GRAMMAR 24 MAKING COMPARISONS
5 Rewrite each sentence, beginning as shown. Do not change the meaning.
a) That's the best meal I've ever eaten.

I've never eaten a ...better meal
b) Fish and meat are the same price in some countries.
Fish costs just
c) I've never enjoyed myself so much.
I've never had
d) If you run a lot, you will get fitter.
The more
e) The doctor can't see you earlier than Wednesday, I'm afraid.
Wednesday is
f) I must have a rest. I can't walk any more.
I must have a rest. I can't go
g) Home computers used to be much more expensive.
Home computers aren't
h) I don't know as much Italian as Sue does.
Sue knows
i) I thought that learning to drive would be difficult, but it isn't.
Learning to drive is
j) Barbara can skate just as well as John can.
John isn't
143
46
a) Your car was cheaper than mine.

cost
Your car cost less than mine did.
b) I'm not as good at maths as you are.
better
You I am.
c) Keith is slightly taller than Nigel.
little
Keith Nigel.
d) Bill was growing angrier all the time.
and
Bill angrier.
e) Sally tried as hard as she could.
did
Sally best.
f) I thought this film would be better.
as
This film I expected.
g) This is the bumpiest road I've ever driven along!
such
I've never road.
h) When you eat a lot, you get fat.
more
The you get.
i) George said he couldn't do any better.
could
George said it do.
j) This year's exam and last year's exam were equally difficult.
just
This year's exam last year's exam.
144
47
:I,
Readyfor testind in live organisms
Hereare someopinionsabout preclinicaland clinical trials. Doyou agreeor disagree?
Agree Disagree
r AnopendayallowspharmaceuticaIcompaniesto be more
transparent policies.
abouttheiranimaItesting it ll
z Manypeopledon'trealize thatanimaltrials
arerequired
by law,
beforetestingin humanscantakeplace.
3 Testanimalsoftenhavebetterconditions
thanfarmanimals.
4 Participating trialsis a goodwayto earnsomeextramoney.

in clinical --t
5 | wouldn'ttiketo riskmy healthasa subiectin clinicaltrials.

6 Heavydrinkers
aremoreat riskthansubiects
in clinical
trials.
7 Volunteersmakea bigcontributionto the fieldof medicine,

no matterwhattheirmotivation
is.
8 lf I wereseriously takepartin a clinicaI

ill, I woulddefinitely study.
It couldbe my lasthope!
48
40 I UNIT4 Readyfor testingin liveorganisms
t Duringan internship at Vine Pharmaceuticals, ttiki, a lab

technician,is learning about preclinicaland ctinical testing.
She has found somegeneralinformationon the Internet
about requirementsbeforean investigationaldrug can be
tested in humanvolunteers.Completethe text with words
from the box.
active r administer. developmentr formulalgo puritV
Inthe preclinical
stageof drugdevelopment,
an investigational
drugmustbetested
extensivelv
in the laboratorv.
Thisisto ensureit wiltbe safeto 1
to humans.Testingat thisstagecantakefromoneto fiveyearsandmustprovideinformation

aboutthe pharmaceutical
composition
of thedrug,its safety,
andhowthe drugwittbe
formulated
andmanufactured.
Preclinical During the preclinicaI

Technology: ' ofa drug,
laboratory
testsdocument
theeffectof the investigationaldrug (invivo),
in livingorganisms
andin cetlsin a testtube(invitro).
Chemistry, andControls(CMC)/Pharmaceutics:
Manufacturing Theresultsof preclinical
testingareusedby expertsin pharmaceutical
methodstodeterminehowto
best r thedrugfor its intended
clinical
use.Forexample,
a drug
thatis intended
to acton thesinuses
maybe formulated
as a time-release
capsule,
or asa
nasaIspray.Regulatory
agencies
requiretestingthat documents -
the characteristics
chemical
composition, a, guality,andpotency- of the
drug's 5 ingredient,
andof theformulated
drug.
Pharmacology/Toxicology:
Pharmacology
is the studyof drugsandthe body'sreactionto
is the studyof thepotentialrisksto the body.
drugs.Toxicotogy
Theresultsof alltestingmustbe provided

to the FDAin the UnitedStatesand/orother
appropriate
regulatory in othercountriesin orderto obtoinpermission
agencies to begin
ctinicaI
testingin humans.
Regulatory
agencies
reviewthespecific
testsanddocumentation
that arerequiredin orderto proceedto the nextstageof development.
49
UNIT4 Readyfor testingin liveorganisms141
2 Useinformationfromthe text in exercise1 to answerthe foltowingquestions.

a Howlongcanit taketo finishthepreclinical
stage?
b Whatneedsto be documented
in laboratory
tests?
c Whatdo regulatory require?

agencies
betweenpharmacologicaI
d Whatis the difference andtoxicologicalstudies?
e Whencana pharmaceutical in humans?

companystartclinicaltesting
3 HndthewordIn ltallcsin the text on pege4o whlchmeans!

a receive,get d fix conclusively
b demand e possible
c makesure f goon
4 Completethe table uslnga wordfromthe text In exerclser.
verb d o c u me n t intend inform
noun permission administration formulation
50
42 | UNIT4 Readyfor testingin liveorganisms
5 iliki is informing a new trainee about what she has learnedregardinga certain investigational
drug at Yine Pharmaceuticals. Completethe excerptusing the correctform of the words in
erercise 4.
First of all, it is the I of the company to complete the preclinical trials
by the end of the year.After that, regulatory agencieshave to give
to commencewith the clinical testing in humans, which is also done at our company. But before
that can happen,our scientistsdetermine how to 3 the active ';
4:
pharmaceuticalingredient into a suitable administration form. We have to
each step ofevery test very thoroughly before the regulatory agencies give their approval to
proceedto the next stage.The 5 must show that the
"'n"'"":':.:,ru sF*.
::Tj::::_:::=:*-$. e,i,#!*.#ds *Fs*_=:=s:-+=#* sEdF
AUDIO
41 Now listen and checkyour answers.

vt
ro
oEscRrBr.cA pRocEss(pql t)
Thepassiveis oftenusedto describe a procesq*We u9eit because it focuseson the action,ratherthan

on the personor thing(agent)doingthe action.Oftenthe agentis unclear,unknown, or irrelevant.
An experiment carriedout/conducted/done/performed.
A triaUstudy
ts/was
A drug absorbed/administered/formulated/manufactured/
prescribed/taken.
Thedata provided/transmitted.
a re /w e r€
A num be ro fe x p e ri m e n t, conducted/done/performed.
SeveraItests
Thecriteria can met.

must be
A study will carried
out/conducted/done/performed.
O Completethe sentencesabout preclinicaldevelopmentusing the correctform of the verbs in

the box.
be administered. be conductede be determined. be formulated. be providedo be used
r Westartedthe trialaftertestson investigational

drugs in vivoandin
vitroovera periodof up to fiveyears.
z Lastyear,resultsof preclinical
testing to comeup withthe best
formulationof the intendeddrug.
51
U N I T 4 R e a d y f o r t e s t i n gliinv e o r g a n i s m s/ 3 : 1
3 Extensive must
documentation regulatory
to the appropriate authorities.
4 A drugintended
to acton theskincan asa cream.
risksto humans
5 Potential in toxicitvstudies.
6 Therequirements
of drugbioavailability howit will
determine to humans.
llow describean SOPor processin your companyusing the phrasesabove.
H 7 Miki has beeninvited to ioin an impromptulab meetingabout drug substanceilPP oroo98,

? which is being tested in dogs.iliki, Linda,an animal caretaker,fake, a biologicallab technician,
and their supervisor,Roger,are talking about a problem.Listento the conversationand decideif
the statementsbeloware true (rz), false (rv),or not mentioned(-).
r told Lindathatthedogswerevomiting.
Someone n
z Somedogswerenot affectednegatively
by the drugsubstance. l_]
3 Lindadoesn'tknowif the animalsin the controlgroupareaffected. t]

thanmini-pigs.
4 Dogsaremoresensitive I
5 Thestudyprotocol
will haveto be changed. I
6 Rogerwill contactthe studydirectorby the endofthe day. L_'.
z Mikiis goingto writethe reporton whathappened. ff
THE!ilSAilDOUTS TR|AIS s
OFCLrt{|CAL
assistschemists
A chemistrylab technician andchemical engineers andrelatedproducts,
usingchemicals
whereasa biolorylab technician
workswith livingorganisms.
studiesis a groupof testanimalsthat is notexposed

A controlgroupin preclinical to the medication under
thisgroupis treatedjust likethe otheranimals,but doesnot receive
study.In an experiment, the active
ingredient.Thisgroupis thencompared withthetreatedanimalsin orderto validatethe resultsof the test.
low-dose/mid-dose/high-dose groupsarethreegroupsof animalswhichreceive

differentconcentrations
of the medication
understudy.
In preclinical
triats,at leasttwo differentanimalmodelsarenecessary:
r Testingis donein rodents(e.9.mice,rats,but alsorabbits,and/orguineapigs).
z Testingis thencarriedout in animatswhichhavesystemsmoresimilarto humans, e.g.dogs,mini-pigs,
and/ormonkeys.
Theactiveingredient
canbe testedin humansonlyafterthesetestshavebeensuccessfully and
completed
hasbeengiven.
authorization
52
44 | UNIT4 Readyfor testingin liveorganisms
GETTIXG I 1IFORTATIOII A1{D TIAI(IlIG SUGGESTIOI{S
Askingfor and clarifuinginformation Makingsuggestions Responding

to suggestions
Couldsomebody fitl me in on ...? | suggestmaking... I'll let you knowwhatwe comeup with.
I'dtiketo knowwhathashappened. I suggestwe take... I'mnot sureI agreewithyouon that.
Doesthat mean...? Wecouldconsider trying...
I haveheard.... ls that correct? So,we'dbettertest ...
8 Unscramblethe words. tlake questionsor sentencesto ask for and ctarify information,
makesuggestions,and respondto suggestions.Notethat eachtime there is one word you
do not need.
r fill in me Couldsomebodyis what on the problemthere'splease?
z correctdoes it thedogs ls responding

that aren'tto thedrug
3 need to figurewe which animalgroupFirst,out is receivingwhat concentration
4 couldWe considertestinggroupwithbutanotheranimalsof
5 would know to prefermini-pigsI use dogs insteadof Personally,
6 later know we come with I'll trials let up you what
Z we put havethe would to I changestudyprotocolimagine
9 Chooseone of the situatlons below,or think of one at your company.Thenfollow the flowchart
to discussthis subiectwith a partner. Usethe Useful Phrasesabove.
- Theamendment
Situations: to a studyprotocol
hasnot beensigned.
- Thebodyweightof the animalshasnot beenfitledout for Day3.
- Atlthe micein the studyhavestartedscratching
themselves.
PartnerA PartnerB
Askwhatis wrong Explain
Askfor clarification Givedetailsandsuggesta solution
Rejectthe solution OR Agreeandsummarize
53
UNlT4 Readyfor testingin tiveorganisms /|.5
10 Rogerneedsto write the requiredamendment.Hereare Linda'snotes,which sum up the points in

the meeting.Readher notes,and matchthe sentencehalvesto makea summaryof the meeting.
Natar
'[he gewral hzalth of thz drys was
rEularly chukd. Iw addituw, thL

overallappearanteand behaio*r of
twitc a day'
eachanivnal vJl$ asse.tsed
OwDaY2, htv',lever, abwrYxalLier
rEardin4 fiod cow*tvtPiwn were
obsewcd shtrtly after adwtntstrattovt
iw the hgh-dose7rouP.'the dogsfood
cownmpiow Nat Louter,whereasthelr uldter
and
cowwrtphtw washryher.'the dogt started retchtvg
obsewaiwn' No
vomttwtgotn'dwereseparatedto allow closer
vlcrc obsewed'thtvglt'
other clinjrat sYrnPtovn"t
Lwthe
Iw coupartsowv,ltrl4the' tngh-doseSroupt' animak
Low-doselwd tuLd'doseJroupssfuwed w cltni'calsYvulttwu
at qLL.
r I fhe anima]s
thatshowedclinicalsymptomsa werecheckedtwicea day.
z I in the high-dosegroup
Ctinica]symptoms to be watchedmore
b wereseparated
intensively.
I fne general
healthandbehaviourofthe werefoundin the low-andmid-dosegroups.
dogs
[ ruomajorclinical
symptoms d werediscovered
soonafteradministration.
l{owwritea shortsummaryof the situationyoudiscussed

in exercise
9.
ultftf,G toE^s
wordsareaddedto makeadditionalpoints,or to compare

Certain or contrastideas.
Adding a relevantpoint Making a comparisonor a contrast

ln addition,/Additionatty, ... ..., whereas...
...not only..., but also... ..., while
Besides,... ...(even)though
Furthermore,... However, .../But...
tl the linkingwordsandphrasesIn Linda'snot$ In exerclse

Underline ro.
54
46 I UNIT4 Readyfor testingin liveorganisms
t2 Usethe ryordor phrasein bracketsto link the two ideas.tn somecasesyou wilt still havetwo
sentences.
r Therewereno clinical
findings group.Thehigh-dose-group
in the mid-dose animals
showed
c.tinical
symptoms.(while)
z Thepulseratewasincreased. washigh.(notonly...butalso)
Thebloodpressure
3 Therewereno clinical
findings
in theoraladministration Therewereclinicalfindings
studies. in
studies.(however)
the intravenous-dose
4 Mini-pigsareeasyto handle.Rhesusmonkeysaredifficultto workwith. (whereas)
(furthermore)
5 Thedrugwaswelltoleratedby rats.lt did not haveanyeffecton bloodpressure.
t3 After getting a closeinsight into preclinicaltesting, ttiki woutd tike to know what comesnext,
and asks a colleaguefor help. She gets tbe fotlowing emai[.
From: jill.sanders@VinePharmaceuticals.com
To: miki.takashi@VinePharmaceuticals.com
Re: Phasesin ClinicalTestinq
Dear Miki
At lunch yesterdayyou asked me to send you some generalinformationon clinicaltrials.Hereis a rough
summarythat might be useful.
Phase I Trials: These are studies which are performed to evaluatethe safety of drugs in healthy people,
and to determinethe pharmacologicalpropertiesof drugs.They are done to find out how the drug reactsin
the body. Toxicity,metabolism,absorption, and excretion are observed and documented.
Phase ll Trials: These are controlled studies conducted to evaluatethe efiectivenessof the drug in a
particularindicationand to determinepossibleside efiectsand risks.Thesestudiesare performedon
volunteersand a numberof patientswith the targetdiseaseor disorder.In this phase,testingdetermines
the safetyand efficacyof the drug in treatingthe conditionand establishesthe minimumand maximum
effective dose.
Phase lll Trials:After gainingevidencethat the drug is effective,these controlledand uncontrolledtrials are
carriedout to obtain additionalinformationto evaluatethe overallbenefit-riskrelationshipof the drug. In
this phase,a largegroup of patientsis studiedand closelymonitoredby physiciansfor efficacyand any
adverse events after long-term exposure to the drug.
Phase lV Trials: These are post-marketing studies after getting approval for general sale. They are carried
out in order to gather further information about the drug's safety,efficacy,and optimal use.
Hope this helps.Call me if you need anythingelse.
Best wishes
Jitl
55
UNIT4 Readyfor testingin liveorganisms 47
Whichphasedoeseachdescriptionbelongsto?
r Phase is performed
afterthereis preliminary
evidence
that the drugis effective.
z In phase , the lowestandhighestdosesaredetermined.
3 Phase is the firstphasein whichpatientswiththe targetdiseaseor disordertakepart.
4 In phase , furtherinformation
regarding
the idealuseof thedrugis col[ected.
5 Phase is the finalphasebeforegettingmarketing

approval.
It{slDEcl|l{tcAt TRTALS
An adverseeventis anyabnormalmedicaloccurrence in
a patientor clinicaltrialsubjectaftera medicinal
product
hasbeenadministered. lt doesnot necessarily
havea
causalrelationshio withthe medicinal oroduct.
Adversereactionrefersto a[[abnormaland unintended
responses to an investigational product
medicinal
relatedto anydoseadministered.
In a controlledstudy,one groupof test subjectsis

exposed to the substance, whilethe controlgroupis not.
Testsub.iects in thetreatmentgroupreceive the
medication understudy,whereasthe controlgroup
receives eithera standardmedication or a placebo.
The
resultsarethencompared to determine the heatth
effectsofthe substance beingstudied.Uncontrolled
clinicaltrials do not havea comparison group.
;: 14 Theclinical trials for RFIrooo89 wero successfuland the documentscan be submitted.Forthis

cf
reason,Vine Pharmaceuticals has arrangeda mock inspectionto preparefor an upcomingvisit
by the regulatory authorities.Listento part of the inspectionand circle the correctendingto the
sentencesbelow.
r wantsto lookat
Theinspector
manual.
a an instruction
datagathered
b the detailed duringtheclinical
trial.
z Theinspector
a did notacceptthe documentationaboutthechangein temperature.
b consideredthe incorrect
changeto the documentation
to be minor.
3 In orderto solvethe problem

a the temperature wasincreased.
b the temperature wasdecreased.
56
/f8 | UNIT4 Readyfor testingin liveorganisms
REQUESTIlIG I 1{FONTATIOI{ ATD RESPO]IDITG DIRECTTY
Givlnginformatlonat lnspections Exptainingand iustifyingdecisions

Herearethe documents yourequested. Letme demonstrate ...
I'llget it immediately. Wehadno alternativebut to ...
Youcanfindthison pagethree. I assureyou...
Thechangeis crossed out,initialled,
anddated. Youcanrestassuredthat we will ...
Letme explainin moredetail... Thatledto...
I cangiveyou morespecificinformationon ... Thisway,you can/willavoid...
t5 the expert(E)or the inspector(l)?

Whowouldsaythis duringan inspection,
r l'llsendforthatimmediately. n
z Ho wdoyouaccountforthecha n g e ? [
3 Youcanrestassured
thatthiswon'thappen
again. n
4 lf youcheckpagesixyou'llfindit at thebottomof thepage. n
5 lt wasinitialled
anddatedbyDrSvenson. I
6 Where
can| findthechange
thatwasmade? f-l
t6 Finda phrasein thedialoguein exercis€r4 whlchmeans:

r Havea lookat ...
z What'syourexplanation
for ...?
3 | assureyou ...
4 Wehavemadea changedueto ...
5 DoI understand
correctly?
Youwantmeto ...
6 Thisis howyoustop...
57
UNlTif Readyfortestingin liveorganisms 49
RichardThompson,the expert responsible for the proiect, is hosting Paut Witliams, a

consultant, for a mock inspection. Work rrith a partner and rote-ptay the inspection.
Pautlttliltiams RichardThompson
Askfor currentstudyprotocol Handoverdocument
Askaboutdocumentation
ofa change Saywhereto findit
Referto a mistakein documentation
Warnaboutpossibleproblems
with authorities Acceptwarning
Askfor explanation
ofthe change Double-check
request
Confirm Explain
thechange
Showsatisfaction
with explanation
Moveon to nextsubiect
18 Thefollowingwordsareoftenconfused.
Putthe correctoneinto the sentences.
lf necessary,
look backin the unit. At least one word of eachpair has beenused in this unit.
illness/disease
r Thereis a historyof lung in the family.
z Hemissedfivedavsof workbecause
of
sensitive/sensible
3 Dogsaremore to drugsthanmini-pigs.
4 ltwasa decision
to cancelthetrial.
affect/effect
5 | felt the of the newointmentrightaway.
6 Theactiveingredient
currentlybeingtestedseemsto thekidneys.
shortly/briefty
Z Theadverseeventoccurred aftertheinjection.
8 Thetrialdirector
spoke to hisstaffabout
thecurrentstatusofthetrial.
t9 Workwith a partner.Readout the definitionsin yourPartnerFile,but do not readout the termin

botd.Canyourpartnergiveyouthe correctterm? A File p. 4, 17
')arl.ef
Pi {tnef B fi l e 4, p /t}
58
50 i UNIT4 Readyfor testingin liveorganisms
Readthe foltowing newspaperarticle.
ExperimentalDrugs on Trial
The parents of a 2l-year-old woman

challenged the FDA. Th.y took the
authoritl'to court after their daughterhad
died of cancer.The parentsfirmly believe
that their daughter might have had
a chance of surviving if she had been
given accessto a potentially life-saving
experimentalcancerdrug that her doctor
had recommended.
Many terminally ill peoplefall victim to
the 'therapeutic misconception that the
objectiveof trials is to cure them. In truth,
clinicaltrialsaremainly aimedat answering Do terminally ill patients have the legal
scientificquestions.In general,their goalis right to try to prolong their lives by taking
to gatherstatisticsto determinewhetheran experimental drugs? The FDA has a clear
experimental drug is safeand effective. position on this subject.It maintainsthat it
On the whole, subjectsin a trial must would be difficult to find a sufficient
be willing to be randomlyassignedto either number of patientsto participatein clinical
the group which receivesthe unapproved trials if it were possibleto obtain the drug
medicationor the onewhich getsa placebo. without actuallybeing a subjectin a trial.
This is the only way to make sure The safety and efficacy of a drug can only
clinical trials serve a scientific purpose. be determined by conducting rigorous
Subjects also have to be aware that clinical trials, accordingto the FDA.
the pharmaceutical company which is
sponsoringthe clinical trial can stop the
trial at any time.
G@[
justifiabte
ls it ethicatty ill patients
to denyterminally accessto potentially
life-saving,
experimental
drugsandmedicine?
Wouldeasieraccess to experimentaldrugshavean effecton obtaining reliabledataon thesafety
andefficacy ofthe drugs?
Whatcanauthorities do to provide
termina[[y ittpatients
withdrugsthatcouldhetpthem?
59
GRAMMAR 26 PHRASAL VERBS 1
Rewrite each sentence so that it contains the phrasal verb in brackets. You may
have to change the f o r m .
a) Sorry, but I haven't found time to fix your bike yet. (get round to)
got round to fixing your bike yet.
b) Oh bother, we don't have any milk left. (run out of)
c) It took me a long time to recover from my illness. (get over)
d) Julie must be too old to bite her nails. (grow out of)
e) I think we've found an answer to the problem. (come up with)
f) I don't think I'm well enough to play football today. (feel up to)
g) Ann is someone I really respect. (look up to)
h) I must arrange to have the kitchen painted. (see about)
i) Please help me. I'm relying on you. (count on)
j) Peter is just like his father! (take after)
60
a) Quite by chance, Brenda met Philip at the station.

ran
Brenda ran into Philip at the station.
b) You'll just have to learn to accept the facts!
face
You'll just the facts.
c) How can you bear so much traffic noise?
put
How can you traffic noise?
d) Charles cheated in his exams, and didn't get caught.
got
Charles cheated in his exams, and it.
e) I visited a few friends while I was in Manchester.
called
I while I was in Manchester.
f) What are you trying to say?
getting
What at?
g) I must go to the dentist, and get my teeth taken care of.
seen
I must go to the dentist to.
3 Complete each sentence w i t h one of the words from the box.
a) I'll send someone to call for the parcel on Thursday.

b) You'll have to work hard to keep with the rest of the class.
c) Jean didn't expect to come up such difficulties.
d) It's not fair. You're always picking me.
e) Terry sang the first verse and then everyone joined
f) I came one of your novels in a second-hand bookshop.
g) I'm not interested in buying anything. I'm just looking
h) Don't you think the manager should deal this problem?
i) George came a lot of money when his uncle died.
j) You look very guilty! What have you been getting up ?
154
61
G R A M M A R 26 P H R A S A L VERBS 1
a) The weather was fine, and everyone was B. the coast.

A) going in for B) making for C) joining in D) seeing about
b) How much money do you manage to ?
A) come into B) go in for C) deal with D) live on
c) There isn't any sugar, I'm afraid. You'll have to
A) run out B) put up with C) do without D) make for
d) I was passing their house, so I Claire and Michael.
A) dropped in on B) came up with C) got on with D) ran into
e) I don't really winter sports very much.
A) deal with B) face up to C) go in for D) get round to
f) Losing my job was a great shock, but I think I'm it.
A) seeing to B) putting up with C) standing for D) getting over
g) Sheila's gone to having a new phone installed.
A) see about B) deal with C) get round to D) ask after
h) I've had to a lot of insulting behaviour from you!
A) look down on B) put up with C) stand up for D) get on with
i) The hotel was terrible, but the wonderful beach our
disappointment.
A) got over B) faced up to C) saw to D) made up for
j) Jack has decided to the time he spends watching television.
A) run out of B) see to C) cut down on D) come up with
155
62
FIRST CERTIFICATE L A N G U A G E P R A C T I C E
5 Choose the most suitable ending for each sentence. Note that some of the phrasal
verbs have a different meaning to the one given in the Explanations section.
a) I can't put up with B.

A) you if you should come to London. B) people who smoke all the time.
C) the plates onto the top shelf.
b) The chairperson of the committee then called on Tony
A) but his line was engaged. B) to make a speech in reply.
C) so that his voice could be heard above the crowd.
c) Mary has been chosen to stand for
A) the bad behaviour of her colleagues. B) herself in future.
C) Parliament in the next election.
d) After my holidays it takes me a few days to catch up with
A) the people running in front of me. B) all the news I've missed.
C) a really bad cold.
e) Small children soon grow out of
A) their shoes. B) all the good food they eat.
C) the habits they have when they get older.
f) I've decided to go in for
A) eating fruit for breakfast. B) a few days rest in the country.
C) a photography competition in Photographer's Weekly.
g) I'm afraid that our plans to open a new factory have run into
A) some old friends. B) a tree by the side of the road.
C) a few unexpected difficulties.
h) We find that this type of tyre makes for
A) safer driving in wet weather. B) the first place it can stop.
C) all smaller types of cars.
i) I saw my old friend John last week. I couldn't get over
A) my cold before I saw him, though. B) near enough to talk to him though.
C) how young he looked.
j) Here people are only worried about keeping up with
A) others who are faster. B) late-night television programmes.
C) the Joneses.
Key points 1 Check any new phrasal verb in a dictionary to see how it is used.
2 Remember that many phrasal verbs have more than one meaning.
3 Phrasal verbs tend to be more common in spoken language and informal
written language.
156
63
Drug safety and regulatory affairs
Tick the departmentwhich is responsiblefor eachof the following tasks:
DrugSafety RegulatoryAffairs
r Reporting
an adverse
drugreaction
to healthauthorities.
-
z Submitting
documentsneeded
to obtainmarketing
for a drug.
approval
3 Monitoring
andevaluating
suspected
sideeffects.
to a physician's
4 Responding report.
dossiers
5 Compiling for submission
to authorities.
forthe patient.
6 Writingthedruginformation
Why do healthcareprofessionalsand pharmaceuticalcompanieskeep recordsof unerpected

reactionsto drugs?
Howmuchshould patients know about possibleside effects beforetaking medication?Why?
lVllAT lS PHARi'IACOVIGI t-lHCg?
TheGreekword'pharmaco' (medicine)
andthe
(watchfulness)
Latinterm'vigitantia' wereput
togetherto formthe wordpharmocovigilonce.
Government pharmaceutical
agencies,
companies, andhealthcareprofessionalswork
togetherto monitorandevaluate suspected 'a a a a
sideeffectsof medicinesto improvethe safety

of dr ugsin us e .
64
52 | UNIT5 Drugsafetyand regulatoryaffairs
AD D IT ION ALEF F EC T S
O F T AKIN GD R U G S
q
Sideeffect - any unintendedreactioncausedbv a
{
drug or medicaltreatmenr.This term is rrsej bv I
the generalpublic, but is often avoidedbv f

medicalauthorities.
Adverse event - an unwantedmedicaloccurrence /
f
which a patient experiences during treatment.

:
This may or may not be a sideeffectof a drug.
Seriousadverseevent (SAE) - an adverseevent
that threatenslife, requiresor prolongs
t Readthe following reporl hospitalization,or resultsin death.
Doctor'sreport:
On24Dec 2010, a woman of unknown age,Maria Gallois, fainted after developing a
sudden, severeskin rash and inflammation all over her body.
Ms Gallois, the well-known opera singer,lost consciousness30 minutes before she had
planned to go on stage.Shewas taken*tohospital and regainedconsciousnessan hour
later. She reported that she had not had anything to eat except some chocolate four hours
before. In addition to small, red, itching spots all over her body, she also reported a racing
heart, a headache,and insomnia after starting on MensamintrMthree weekspreviously.At
the hospital, the patient showedevidenceof hyperactivity, accompaniedby confusion and
agitation. Subsequently,MensamintrMwas discontinued,but the symptoms persisted until
a strong sedativewas administered.After 24 hours, all symptoms exceptfor a mild skin
irritation had subsidedand the patient was dischargedfrom hospital. Some symptoms are
suspectedside effectsof MensaminfM.
Vital signs: temperature 100'F (38.8"C) and blood pressure160/110

Knownallergies: peanuts,penicillin
Current medications: two 100 mg MensamirfrM lozengestaken once daily for improved
short-term and long-term memory.
Mimifem oral contraceptive0.2 mg daily.
The patient has a history of hlryertension, mild heart palpitations, high adrenalin levels,
and often suffersfrom insomnia.
Frede.rirk/vI. WrgW
FrederickM. Wright,MD
AttendingPhysician
65
UNIT5 Drugsafetyand regulatoryaffai.s 5:l
l{ow answerthe following questions.
r Whatwerethe patient'ssymptomsbefore
shewasadmittedto hospita[?
2 Howwasshetreatedby herphysician?
3 Whatwasherconditionwhenshewas
fromthe hospita[?
discharged
What evidencepoints to Mensominfil as the causeof the symptoms?

What evidencesuggeststhat other factors may be responsiblefor the symptoms?
2 ilatch the following symptomsin bold in the doctor'sreport with their definitions.
r I hypertension a . sleeplessness
z I rash b generaldiscomfort,
badfeeling
3 [ palpitation c red,warm,andswollen
4 [ insomnia d youfeellikeyouwantto scratch
5 [ inflammation e heartracing
e I itching f highbloodpressure
7 [ irritation g a lot of spotson the skin
3 Gonnectthe following sentencehalves.Thenput them in the correctorder to makea casereport.
1 n fromthe patient'ssister
A reportreceived a the attendingphysician
reducedthe dosage
to ro mg perday.
z I RfterhavingtakenMensamlntrv,the b andthe symptoms

cannotbe ruledout.
patient
experienced
3 n A correlation
between
MensomintrM c headaches
andinsomnia.
a I ffrepatienthasnowcomp]etely d indicated
that shehada historvof
hypertension.
5 [ thepatient,
nter examining recovered
andis backon stage.
Correct
order:
66
54 I UNIT5 Drugsafetyand regulatoryaffairs
REPORTIl{G ADVERSE
SEVERE EVEIITS
TO HEATTH
AUTHORITIES
companiesuse detailsfrom doctors'reportsto inform the authoritiesin a case report.

Pharmaceutical
Patienthistory Druginformation
Thepatienthasa historyof ... ...areknown/suspected sideeffectsof thisdrug.
A reportwasreceived fromthe physician indicating tL;rrg1v735 admi ni stered
for { c* ndi ti on).
t hat . . . Eyedropswereinstilled.
Beforethe event,the patientwason the fottowing A bandage/cream/l oti on/oi ntment w asappl i ed
medication: ... (tothe skin).
Descriptionof adverseevent Assessmentof adverseevent

Afterexamining the patient,the physician
... iDrugiis (not)betieved
to be relatedto the event.
Aftertaking(drug),the patientexperienced ... An interactionbetween(drugx) and{drugy) was
At thetimeof the report,the patient's
condition suspected.
was/remained unchanged. between(drug)and (symptom)
A correlation can/
At thetimeof the report,the patientwas cannotbe ruledout.
recovering/had completelyrecovered.
Thiseventledto the oatient'sdeath.
4 Pharmaceuticalcompanieshaveto submit a Safety Informationand AdverseEventReportto the

FDAand to the local authorities immediately.The medicaldirectorof your companyasks you to
completethe form basedon the doctor's report on page52.Completesection 8.5 of the FDAform
usingthe phrasesbelow.
a a historyof g correlation
between
b a reportwasreceived h showedevidence of
c the patient
afterexamining i suspected sideeffects
d allsymptoms hadsubsided j the patientreported
e be ruledout k vitalsigns
f wasconcomitantlytaking
67
U N lT 5 Drug safety and regutatorvaffar':
U.S. Oca{lmad ot rbr|lr nd Human Sldicra Fm Apgrod: Ota b. GlGO2gr €F r2R'Ar'

SeOIgffioffi
IleoWntcr
For VOLUNTARY reporting of
advercewents, product
:t problems ar
and
product use enots
erorc FU 6 6 t
Ihe FDA S.irty Iniormedon and
AdneEc Evcnt Roportng Program Page I of_
of
O.t otglrth:
! rcmar _rb
a1
,, tOO;;1 1;C-
Aaril-G uaknoutn i2
hqti&ne
! uau
-kg
, e.6 ct v.. u. unMw4 gw Mw, tw
tqwtgMad) slopp.d 6 DG! R.dcrd?
!. E Advo. Ewrt Prcd$t lhourn (a g., daLcts/nalturctlfrs)

rt sbrtel mclicA'oa 3ueth rt ffivcs [xo f]ooert
n
E PDdEr U.. Ercr E PEblrm rdrh Dlttmni t{rnqtrctunr ot 3.n. lhhlnl rz prtof @ saE p2 l-'1y63 flp6 flDerl
9fagrca! or Rad bf u{ (h&M)
2. Oqbon6 Aflbui.d to Adva[! Evrni
(Che* il that apdy) *1 i. EY.nt Ropp..Dd Att r
o.ttt, E Di$tttity d Pmaut Dm.gr
,ne rr.o F, 2 h rvt^(4 nt c^C R.lntrcd60on?
E _
t2 tt flvo lNo 5oocnr
Ern.-^nn^,ffW) DcogairatAnm*yairoDctu
q polcngcd plly.s llNo ll|ml
6. Lot I 7. Erddilq Ort
E Holpft.llzdbo - hild fl Oto Saws ltmportent lil,ldiel Evani!) - Apgtv
E R.quirud Int6vatin io Psffl Pam.ni lmpdrenuDma0c (O.vicc!) *1tZ3tr{6"0 t1 {w c 2... l. IDC f qt nhu. lO
3. Ort o, Zu.fr (nn&lw | ,1.lr.t ol thlt R.pon @n^tduyw)

*2 32 A A knautr
,z lz+1L .. . I t 2- / 2- Llz . . .
q l. Bnnd Nana
_1 froma physician indicating

that a womanhadfaintedafterdeveloping a
sudden,severeskinrashandinflammation all overherbody.Shewastakento
hospital andregained consciousness 3o minuteslater._2 nothavinghad
anything to eatbuta chocolatecandybar4 hoursbeforehand. In additionto small,
red,itchingspotsall overherbody,shealsoreportedsufferingfrommildheart
palpitations, headaches, andinsomniaafterstartingon MensaminfrM threeweeks
previously. Thepatient_r the followingmedication: Mimifemoralcontraceptive
pillo.z mgdaily.Asto heremotional stateafterhospital admission, the patient
_+ hyperactivity,
accompanied byconfusion and a feelingof agitation._5,
the attendingphysician discontinued MensamintrM andadministered a strong
sedative.Afterz4 hours,_6 exceptfor a mildskinirritationandthe patientwas
released fromhospital.Symptoms arc _7 of MensaminfrM, althougha _8
herpeanutallergy, MensamintrM andthiseventcannot_e.
_'o: temperature loooF(18.8"C); bloodpressure r5o/no.
Knownallergies: peanuts, penicillin.
Thepatienthas _" hypertension, hearttrouble,andinsomnia.
7. 6ar hi,.,.nt Hl.bry,lnchdlne Pmxlalng lrdlc.l CddldoE (r9.,

ilaqiE, Nc, fl*iry .nd .l@hol @, liadkid6y pr*B, a|o.)
'/ligoarcy,
- atlarSX b ?r.^n6 ttothtct w.ndtfinpy &B (cxd!<lo b@t@t o{ w0
- htqrL patp;httcas Miai(cn - d..Z.s aaktoul

- hetdaohcs
_ iagr.ir'',a;t
mm anc M|u
Nmt Ca R,VCEUS PHARt4ACeuTt CA t-S
lorlw: ll12fol26btar5kzAc fu4lk t3
! vcs ! tto E Rctumcd !o Mautduc d:
Cltyi Ecrlit^ sr.ro: zp: t4 14?

thona l E{.ll
f . il.m, Slnngti, Imtnsufi (tod N&rcl l'0./)
ACasaur-i'r4z ,0+7-30-t9 +tsi+O+

ffin, .4.Abo R.9o.t d b:
2. H.din P.ofrnloml?l 3- Occup.iloo
Nfr: flvcr lHo | ?tl d#Zcr ! uanraaro

Studh: 5. ltt@ do l.OTwd t{ trtftlt dl*lo..d I usr<ry
Uwlbctff: bhnnffird,paor'f h$a.bor: O ! oi*omnnrp.u
a Gql d@! mt stlitulr the oroducl6us€d
9roducl 6us€d or ontribubd b fE ffi
68
I
56 | UNIT5 Drugsafetyandregulatory
affairs
HEATTH
AUTHORTTIES
AilD USEFUL
TERTS
Thenamesof heatthauthorities
andothertermsusedin pharmacovigilance
areoften
shortened.Herearesometypicalexamples:
EMEAEuropean Agency(EU)
Medicines
(US)
FDA Foodand DrugAdministration
MHRAMedicines
andHealthcare
Products (UK)
RegulatoryAgency
PSUR Periodic
SafetyUpdateReport
SAE SeriousAdverseEvent
PersonResponsible
QPPV Qualified for Pharmacovigilance
5 TheFDAform hasbeensubmittedto the authorities.A meetingwith the ChiefExecutiveOfficer

(CEO),the tedicat Dlrector,andthe RegulatoryAffairstanager is plannedto discussthis SAE.
Tickthe topicswhichyou think they witl discussat the meeting.
I process
approvat
f clinicaltrial
I doctor's
report
I lastauditreport
I QualityAssurance
I soes
AUDIO
A llow listen to the meeting in which Karl (CEO),Fred(Headof Regulatory Affairs), and Caroline
a7t
v
(Headof Pharmacovigitance)dlscuss the SAEand its implications for the company.Are the
followlng statements true (r') or false (t)?
r I Therearetwo dosageformsof MensomintrM

currentlyon the market.
z I Theseriousadverseeventis clearlylinkedto Mensamintrv.
3 I Thedocumentationfor the newdosageformof MensamintrM

wilt be submittedto the
authorities
soon.
4 I Hearttroubleis a knownsideeffectof MensamintrM.
69
UNIT5 Drugsafetyand regulatoryaffairs 5?
9€qu$ry-qNg$t!$$t ASr(txG TBOUTmPUCATTOilSFORA DRUG
It couldhavebeendueto ... Howdidthe clinicaltrialsgo?

It is dueto pre-existingconditions. Whatis the statusof approval?
Theevidence is conclusive/inconclusive. Howfar is it fromapproval?
A reaction to the productcannotbe ruledout. Couldit jeopardizeotherproducts?
Whatdoesit meanfor the productsin the pipeline?
7 Rewritethe fotlowing statementsand questionsusing the Useful Phrasesabove.
r lt resultedfroman old illness.
z Willit causeproblemsfor otherproducts?
3 Maybethe sideeffectwasa resultof takingthis product.
4 Howsoonwillwe get permission

to put the producton the market?
5 Werethe clinicaltrials
successful?
6 Thefactsneitherprovenordisprovethis.
7 Howwillthis affectotherproductswhicharenotyet on the market?
8 Thisproductmayor maynot havecausedthe reaction.
70
58 I UNIT5 Drug sa f et y and
r egulat or y af f air s
8 In orderto get approvalto sell a newdrug,a companyhasto compiledetaileddocumentation

with all the informationrequiredby the drug authorities.Matchthe followingsectionswith
their descriptions.
1 Administrative
Data
2 Common
Technical
Document
Summaries
Quatity
4 Non-clinical
StudyReports
ClinicalStudy
Reports
a biological, andpharmaceuticaI
chemical, documentation quatitycontro[,
withmanufacture, and
testingdata
of quality,
b overviews clinical,
andnon-clinical
data
c documentation trialsandpost-marketing
aboutclinicaI information
d general
information,
suchasthe marketing
authorization form,aswellas product
application
characteristics
andlabetting
pharmacology,
e studyreports, pharmacokinetics,
toxicology,
andreferences
P I L V S . P IL t
n r a n yp e rs o nta k i nga drugcanbe foundi n the ' P l L'or pati ent

lm por t a ni tn fo rm a ti ofo
inf or m a ti ol n
e a fl e t.
Su c hi n fo rma ti oi ns a l socal l edthe pati entl eafl et,
pati entpacket,or
package insert.In the US,it is alsoreferred to as a patientinformation sheet(PlS),or
m edic a ti ognu i d e .
Note:WhenyoutatkaboutPlLs,sayeachletter.lf not,it mightbe confused
with 'pilts'.
-
Hereare your pills-
and here is your PII=
71
UNIT5 Drugsafetyand regulatoryaffairs 59
9 Readthe email from the Headof RegulatoryAffairs and answerthe questionsbelow.
From: Fred Crow, Head of RegulatoryAffairs

To: RegulatoryAffairs staff, especially medical writers
Re: Recentaudit, readability,and warnings
Dear RA staff
ljust wanted to give you a brief update on the self-inspectionconducted last week by QA.
Most of the resultswere very positive.lt seems our documentationis of a high standard,
especiallywith respectto completenessand technicaldetails.However,in terms of
readability,we can still make some improvementsin future patient informationleaflets.We
need to rememberthat not only healthcareprofessionalsread these PlLs, but also patients.
In addition,I have noticed somethingwhich, I think, some of you can improveon. lt has to
do with drug warnings.Yes,we do need to let patientsknow of any possibleside effects.
But, no, it is not necessaryto alarmthem unnecessarily.In other words, in future when
describingpossibleside effectsfor products in the pipeline,we will need to differentiate
more clearly between frequent and rare risks. ln the case of the latter,we will need to be
less direct in order to increasepatientcompliance.
Let's talk about these two points at our departmentmeetingon Friday.I will also be asking
Wendy,our seniormedicalwriter,to coach junior staff members.
Best regards
Fred
r Whatarethe strongpointsin thisdepartment's

documentation?
its documentation?
z Howcouldit improve
haveon patients?
3 Whateffectcoulda changein the styleof language
72
60 | UNIT5 Drugsafetyand regutatory
affairs
1() Wendy,the seniormedicalwriterin the Regulatory

Affairsdepartment, is trainlngf,iark,a iunior
i ;D
1 i staffmember.Bothwriteandtranslate patient
informationleaflets.Listento the dialogueand
addthe followingheadings
to the PILfor Mensomintn.
Befsreyoutakethisproducto Further informationo Howto storeo Howto take/use.

Readthisleafletcarefully
becauseit containsinformationyouneedto know o
Possible
sideeffects o Whatthe product is,andwhatit is usedfor
PATIENT
INFORMATIONLEAFLET
MENS A M I NT *
Keepthis leoflet.Youmoy needlo reod it ogoin. lf you hovefurtherquestions,pleoseosk your

doctor,phormocist,or heolthcoreprofessionol. Thismedicinehos been prescribedfor you
personolly.Do not possif on to others,evenif their symptomsore similorto yours.
Mensomint'"is o lozengeto supportincreosedoncenhotion. Regulorusecon leod to o morked

improvemenlof both short-term
ond long+ermmemoryond logicolthinkingskills.Theoctivesubstonce
is mensogifotum.
Other ingredienisore peppermint,oil, sugor,tolcum,ond o preservolive.
3
Do not tokeMensomint'"if you ore ollergicto peonuts.
lf you hoveo hisloryof heorltrouble,consultyour doctorbeforetoking.
4
Toketwo lozengeso doy, morningsond eorly ofternoons.
Somepotientsmoy experiencelossof sleepif the lozengesore tokentoo lofe in the doy.
6
Storebelow 25'C in o dry ploce.
CoduceusPhormoceuticols
'l54
Freshfield
Street
Milton Keynes
73
UNIT5 affaia Gl
Drugsafetyandregulatory
cryllrc GEi{ERAL
ADVTCE glv!]tc STnOilG
WAnilrilGS
Mensamintrumay causedizziness. Do not useltakeMensamintrilif ...

Mensomintruconinteractwith othermedicines. Stopuseandaska doctorif ...
Likeall drugs,this medicinecancausesideeffects. Keepout of reachof children.
IJseMensomintruwith cautionwhiledrivingor Tellyourdoctorimmediately/right awayif ...
undertaking dangerous activities. Youmustnot drivewhiletakingthisdrug.
It is possiblethot you mayreceivethis medicine,or Youshouldnot takeMensamrnf rn if you have
an alternative
mavbe used. a historvof ...
tl Here is some lnformation from the PIL for a new drug called Pogoloxrn. Match the following
sentences halves used in the leaflet.
t PogoloxrMmay cause a are allergicto any antibiotics.
z Tellyour doctor right away if b your temperaturecontinuesto rise.
3 Y ou m us t no t c operatemachi neryw hi tetaki ngthi s drug.
4 Do not take Pogoloxru if you d this medicinecan causediarrhoea.
S Stop use of Pogoloxrn immediately e seriousliver damage.
5 Lik eall ant ib i o ti c s , f i f you experi enceany chestpai n.
t2 Ghoose you know.Writesomegeneraladvlce(GA)andsomestrongwarnings(5w).

a medicine
tlark eachsentenGeeitherGAor 5W.
. [ ___l l
z [-*l
3 [-_l
4 l--l
t'----'l
)- L I
6[-_l
7 f-l
13 A patientspeaksto a drugsafetyspeciallstaboutcurrentsymptomsposslbtyrelatedto a drug.
P.{ ner A File s. p.t:

Parlnsr I fit€ 5, p. /9
eyent.Usethe doctor'sreporton pate j5 as a model.

Writeup a reporton the aboveadverse
74
62 | UNIT5 Drugsafetyand regulatoryaffairs
Readthe following newspaperarticle.
Fatal fakes - counterfeit medicines

Imagine that it is your job to monitor drug safety. With the advent of online pharmacies, open
One day a report with a very unusual adverse borders and uncontrolled chemical laboratories
event lands on your desk. It has to do with one of all over the world, the number of counterfeit
your well-establishedblockbuster drugs. Suchan drugs is on the rise, not only in developing but
event has never happened to either test subjects also in industrialized countries. This lucrative,
in clinical trials or to any patients recorded in organized 'pharmaceutical crime' poses a sub-
post-marketing surveillance. Of course, you stantial threat to public health. For this reason,
investigatethis occurrencebylooking for similar some countries are passing stricter regulations
side effectsin the documentation and report it to and implementing tagging systemsto help trace
the authorities. Still, nothing even vaguely the sources. They are also developing better
simi,lar can be found for either the API (active chemical analysis equipment to quickly deter-
pharmaceutical ingredient) or any of the mine tablet content. There is also a danger that
excipients. The patient's reaction to this fake pharmacopeias (the pharmacist's'bible')
prescription drug does not even make medical with incorrect information could be used.
sense,given the chemicalsinvolved. ,\ Therefore, in Europe, for example, steps have
been taken to use holograms to prove a
fust a freak reaction? Perhaps.Or maybe it has pharmacopeia's authenticity.
nothing to do with your medicine. It has the
same packaging, same colour coating, same Despite more international co-operation in the
bitter aftertaste, but not the same ingredients fight to stop counterfeit drugs, some countries
inside the pill. Is this a fake drug? have unfortunately not taken action. They are
still treating this problem as if it were about
Fakedrugs may contain
imitation designer bags, fake watches, or
. a worthless placebo
alligators on T-shirts.
. a lower concentration of the sameactive
ingredient
o a similar, but different substance
. a totally different, potentially dangerous
substance.
a Inyouropinion,howhighis the riskof counterfeit

prescription drugs?
a Whoshouldtry to stopsuchcriminalactivity?
Theindustry? Thegovernment?
a Shoutdonlinepharmaciesbe banned, or moretighttyregulated?
a Aredrugsin yourcompanyalsotestedfor authenticity in the caseof adverseevents?
75
Complete each sentence w i t h a suitable form of the verb in brackets.
a) I really miss (play) playing tennis like I used to.

b) I'm sorry. I meant (write) to you, but I've been busy.
c) Martin failed (pay) the rent on time yet again.
d) It's not worth (buy) a return ticket.
e) Have you ever considered (work) as a teacher?
f) I promise I won't forget (feed) the cat.
g) We've arranged (meet) outside the school at 4.30.
h) If you've got a headache, try (take) an aspirin.
a) Jack said that he hadn't cheated in the exam.

cheating
Jack denied cheating in the exam.
b) It was difficult for me not to laugh at Wendy's letter.
help
I at Wendy's letter.
c) I'm sorry but you have not been appointed to the post.
regret
I you have not been appointed to the post.
d) I needed a drink of water and so I stopped running.
to
I stopped running water.
e) I think it would be a good idea to take the train.
taking
I the train.
f) Don't forget the lights when you leave.
off
Don't forget when you leave.
g) I think Derek has forgotten the meeting.
appears
Derek the meeting.
h) My neighbour said he would call the police!
threatened
My neighbour the police.
168
76
G R A M M A R 28 VERBS F O L L O W E D B Y - I N G O R I N F I N I T I V E
3 Complete each sentence with a suitable form of the verb in brackets.
a) Pauline couldn't manage (eat) to eat all the ice cream.

b) I've decided (not sell) my bike after all.
c) A witness reported (see) Terry at the scene of the crime.
d) William pretended (not notice) the 'No Parking' sign.
e) I suppose I tend (buy) more books than I used to.
f) Sometimes I regret (move) to this part of the country.
g) Did you notice anyone (wait) outside when you left?
h) Mark expects (finish) work round about 6.00.
4 Complete each sentence w i t h a suitable f o r m of one of the verbs in brackets.
a) Mary was so angry that she demanded.. to see the manager.

(demand, hope, risk, stop)
b) The weather is so awful that I don't going out this
evening.
(fancy, like, try, want)
c) The children could hardly to leave their pets behind.
(bear, forget, regret, seem)
d) John to let his children go to the concert.
(afford, avoid, refuse, stop)
e) If I give you the information, I losing my job!
(expect, mean, prepare, risk)
f) What do you to be doing in ten years time?
(begin, expect, remember, suggest)
g) Do you to tell the police about the missing money?
(admit, confess, deny, intend)
Key p o i n t s l Check new verbs in a good dictionary as it will show how they should be used.
2 Note that some verbs can be used in different ways with changes of meaning.
169
77
GI
ri
o, Production and packaging
Whichof these signs would you erpect to flnd when you visit a pharmaceuticalcompany?
Do you knowwhat they mean?
5rE
AU0to
A\ A self-hetpgroup for cardiacdiseasesis visiting RRBPharmaceuticals. Henryl{aylor, a

w (PR),
15 representativefrom Public Relations welcomes them. Listenand answerthe questions.
r Whatdid RRBproduce
originally?
z Whatarethe visitorsnot allowedto do?
3 Whatdo theyhaveto do?
4 Whencanthe visitorsasktheirquestions?
78
64 | UNITG Pro du c t ionandpac k aging
EXPRESS|l{G ilt flrE

r$OmEl{TS
Past Specifyingparticularmoments
Whenthe componywasfounded,it onlysold Whilewatchingthe fi[m,...
one product. Duringthe tour,...
ln thepastwe produced
everything
ourselves.
Present Puttingeventsin order

Nowadaysfioday manyof our productsareproduced... Afterthe meetinghasfinished,we will ...
Meonwhile,.../ln the meontime,... Onceyou haveseenthe company, you will ...
By the timewe metthem,the companyhad...
2 Undertinethe most suitable expressionto completethe sentences.
1 In the past,/ In the meantime, requirements havereacheda veryhighstandard.

z Whenit wasfounded,/ Nowadays, the companyonlyhadoneproduction site.
3 In the meantime, / When it wasopened,they havedevelopeda numberof well-known products.
4 While/ Duringyou arewaiting,youcanlookat thesebrochures.
5 Inthe past,/ Meanwhile, ourcompany is oneof theten largestdrugcompanies in Europe.
6 Bythe time/ Duringthe safetyfilm,I will giveyou moredetailedinformation on the company.
7 Once / While the tour is finished,you wilt figveseenthe mostimportantproduction areas.
l{ow talk about your company.andiob. Useas many of the Useful Phrasesaboveas possible.
3 Put the words into the correctorder to makesentences.
r companyto The used powderonly produce

effervescent
z and processuncomplicated
simpleThe be productionto used
3 documented
use clothingThe didn't be specifications
to
4 regulationsstrict to company'sThe safetybe didn't so use
5 inspectionsdidn't so authoritiesbe Thereuse many by to
79
UNIT6 and packagirq 35
Production
4 ilow look at thesesigns.tatch themto the termsbelow.
7 facemask fj 5 overshoes i,
2 haircoveringI 6 shoes t-:
protective ir
3 labcoat = 7 rubbergloves t ,,_l
4 overalls n 8 safetygoggles ll
Doyou or others at your companyhaveto wear any protective clothing? Why?
Llstento StephanieBakertake the self-help group on a tour of the productionfacllities.

6 '5
16 Tick the protectiveclothing items mentionedin the list above.
6 UYhichdiagramshowsthe persondressedcorrectty,accordingto Stephanie'sinstructions?
80
66 i UNIT6 andpackaging
Production
Grvllrc !ilSTRUCTIO]rS
lf you giveinstructions
in a verydirectway,it maysoundimpolite.Therefore,
it is importantto watchyourtoneof voice,andhowyou phraseyourinstructions.
Notethatwhenyoutetl peopleto do something mandatoryif you adda simple'please',

it makesyourinstructionssoundmuchnicer.
e.g. Pleaserememberthat the overshoesare only allowedto touch the white orea.
Notethat'mustn't'means thatyouarenot allowedto do something.

e.g. Theremustn't be more than threepeople in the gowning room at a time.
Politeinstructions
Couldyou please...? Pleaseremember/Don't forget...
Wouldyou please... ? Pleasekeepin mind...
Pleasemakesurethat ... l/We needyouto ...
7 Listento the instructlons.Arelhey polite O, or impolite@?Tickthe correctanswer.

d!
'7 40r@n
'O r @n
, O[ @n 50u@n
3 0 I@n
Rewrltethe impolltes€ntencerin a pollteway.Practisesayingthe sentencespotitety.
7
Llstento the tour again.tUhatshouldStephanie

dodlfferently?
SAIETY
VS.SECURITY
Safetyis the freedomfromdangeror harm,whereassecurityis the

protection fromthreats,suchas attacksor crime.
I Lookagalnat thesignsat the beginningof the unit,andgiveappropriate

instructlonsfor them.
3
4
)
81
UNIT6 and packagng 67
Production
Nowlook at these signs. Giveappropriateinstructionsfor eachone.
at rt rm
r1l n Bl f4l
30
3
9 Thegroupmoyeson to seethetabletproduction
unit at nnB.look at the diagrambelow.
! + sieve
flr nuiabeddryer ! s Tabletpress
[ 6 rxcesspowderremover
82
68 I UNIT6 andpackaging
Production
of the production
Readthe description process,
andnumberthe stepsaccording
to the diagram.
A I goupa spiral,
Asthetabtets theyareshaken, powder
andtheexcess isvacuumed
off.
Thepressed tabletsareput intoa drumandstoreduntitit is timeto coatthem.
B LJ In the granulator,
the ingredientsaremixedto createa wet mixture.
cE ' Thewet granulesarepressedthrougha sieveon theirwayto the fluidbeddryer.
D fl Thegranulesareair-dried.
h L__ Thedriedgranules arestampedintoa mouldto formtablets.
F T Dryingredients areweighed andtransportedto thegranulator bythe hoist.
DEscRrBrlrc (plnr z)
A PRocEss
Thepassive
canalsobeusedwhentheagentis known
or
relevant.
Forthis,by + agentis added.
Themoisture is removed by the hotair in thefluid

bed dryer.
Thegranules are transported by the hoist.
10 Ghangethese activesentencesinto passivesentences.
Example: Active:Thetabtetpressstampsthe driedgranulesintoa mouldto formtablets.

Passive:Thedriedgranulesarestampedinto a mould to form tablets.
r Thehoisttransports to the granulator.

dry ingredients
z A strongflowof hot air driesthe granules.
3 A shakerloosensthe excesspowder.
4 A vacuumsystemsucksup the excesspowder.
5 A drumholdsthe pressed
tabletsuntilit is timeto coatthem.
83
U N ITG P roducti onanC :ac<as -; 6[}
f,"
tt
tt After the tour of the tablet productionarea,the visitors are given a presentationon some
18 different aspectsof the pharmaceuticalindustry. Listento part of the presentationHenry Xaylor
is giving to the self-help group on one aspectof compliance.Decidewhetherthe statementsare
true (/) or false (X).
r at theendof hispresentation.
i ] Henrywantsthevisitorsto asktheirquestions
haveto complywithGMPguidetines.
companies
z [__]eharmaceutical
3 f] Thedifferentcolourzonesonthefloorsindicatetheseparationofcertainfunctions.
a [-l nuthorities comeunannounced.

sometimes
equipment
5 [ I Production untilit is takenintooperation.
doesnotneedto bevalidated
G I V I l { G P R E SE I {T AT IOl{ S
Welcomingthe audience Deatingwith interruptions

ladiesandgentlemen.
Goodmorning/afternoon, CouldI pleasefinishwhatI wassaying?
I'mhappyto welcomeyouto our company. lf I coutdiustfinishwhatI wassaying...
Introducingyourtopic Dealingwith questions

Letmegiveyoua briefoverview of ... Therewitl be timefor questions
aftermytalk.
I'mhereto giveyousomeinformation on ... FeeIfreeto askquestions as we go along.
Today,I'll be talkingabout... lf youwouldliketo askanything, go ahead.
Signposting Finishing
Movingon to the nextpoint,... Finally, I wouldliketo add...
As I mentioned ...
earlier, A s a.fi nalpoi nt,I w oul dti keto say...
Comingbackto ... Torecap,...
Letmecomebackto whatI saidbefore... I hopethi shasgi venyouan i deaabout...
Addingpoints
t o t h i s ,...
I naddit ion
Moreover/ Furthermore. ...
Apartfromthis,...
t2 Nowlisten againand tick

the phrasesyou hearin the
box above.
84
70 | UNITO Productionandpackaging
tf HereareHenry'shandwrittennotes.Whichpartof the presentation

dotheybelongto?
I
a) EnioYwg c) bniLdLvgs' ,
ni i^'z b) Cowtwte
'o owto cLatliA'
/) what ts packagwg tralnlry
F .: J
q/'lP? ""- "'s
e) Iwerruptivg Parb of a Pre^tentatww:

a ch?',klirt
OK . 1) Wdcomeand introductww _ ff
z) Handlivg qur,,rti^ow-
l
t'--- 3) State the topic _ l
fl nu P 4) Maiw body - L,
5) Sqm.martze_
l
..'ti 6) Iwite ftrul quertitw - Opw quartitw?
7) Finirl4 - Z
t4 ilow lt's yourturn.Ghoose

a topicfromany* rn" previousunits,or fromyourfieldof expertise,
andpreparea shortpresentatbn.Usethe checklist.
t5 AfterHenry'spresentatlon, thevisitorsseethe packaging

area.Heexplainsthat packaging
protectsthe qualityof the productsduringshippingandstorage.Howeyer,therearealways
riskslnvolved.Lookat the diagrambelow.Whatriskswouldyouadd?
humidity
:-A-z
I
( R,sK
)
primarypackaging
material
-,\/\--
I
Whywouldthey bea risk for the productquatlty?
85
andpackaging 7L
UNIT6 Production
t6 Aretheseprimaryor seconderypeckagingmaterlalr?Couldthcy beboth?WriteP tot geimaty,

5 for secondary,or B for both.
PRIMARY PACKAGING
ANDSECONDARY Primary packagingis the material
which
is in direc! confaet with the proAuct
i_-J
SeconAa.ry paekagingis aoy

7acka9in9
malerial that is r.totin direct conto"l
wifh fhe product
tT ilatch the typesof packagingfromexercisei6 wlth thelr descriptionsbelow.

r A(n) devicewhichreleases
is an aerosoldispensing medicationintothe mouth
of the patient.Themedicationis breatheddeeplyintothe lungs,or staysin the mouthor throat.
z A(n) is a typeof single-use and is usedfor pharmaceutical

plasticcontainer,
productsaswellas for otherconsumer goods.Theproductis placedin the formedcavityand
sealedby tiddingfoil.Theproductis removedby pushingit throughthe foil.
r A(n) tubeusedfor puttingmedicine

to a ptastic
is a needleattached intothe
bodyor removing
btood.
/+ A(n) glasscontainer
is a multi-use witha twist-onlid.lt canhold
or anykindof fluidsor solids.lt canbe openedandclosedseveral
pharmaceuticals, timesuntil
thecontentsareusedup.Sometimes a desiccant intothecapsothatthecontents
is integrated
remaindry.
s A(n) bagcontaining
is a smalldisposable an individual
doseof the medicine.
It oftenhasa perforation
lengthwise whichcanbe torn open.
6 A(n) to the primarypackaging

is a pieceof paperattachedwith adhesive to
identifyit andgivedetailsconcerningits ownership,
nature,and/oruse.
Which primary packagingwould you recommendfor the following mediclne?
CsUghsyrup . nosedrops ' ointments' suppositoriesr tablets
What products does your companyhave?What type of packaglng ls used?
86
72 | UNIT6 andpackaging
Production
18 Whichof the verbsin the box are usedwith the following primary packagingforms?Why?
press. pushthrough. remove. tear o twist
1 Synnge 4|,ar
z sachet s inhaler
3 blisterpack
CH!LDPROOF
VS.ELDERLY-ACCESSIBLE
is doneto makepackaging
A lot of research childproof,
i. e. a childcannotopenit alone.However, at the
sametime,the elderlymusthaveeasyaccessto their medication,i. e. it needsto be elderly-accessible.
19 Read the foltowing tert about childproof packaging and unscramble the letters in the brackets
to find the correct word.
The latest i _1 (vatinionson)in childproofpackagingnowadaysentail sophisticated
' (sacnihmsem)
that arephysically
easyto open,evenfor the e 3
(dyelert)
or infirm,but that requireactionsto be'ftrought
throughin a waysmallchildrenwou]dnot
bec a (aaclbep)
of. Psychologists,
e : (gieneesrn),
anddesigners
have c 6 (bocallradeto)
andcomeup with the fotlowingstate-of-the-art
features.
l{ow matcheachcontainersystemtype to the action neededto use it.
r f-] slide a A closuremustbe pusheddownbeforeit canbe

unscrewed.
z [] poke b A firstlayermustbe peeledoff a blisterbeforethe
drugcanbe pushedthroughthe secondlayer.
3 l--l push-screw c A closuremustbe sgueezedbetweentwo fingers

beforeit canbe unscrewed.
4 :-' squeeze-screw d A containerwiththreebuttonsthatmustbe alignedin

orderto slideoff the lid.
5 .] peet-push
system e A tubethat canonlybe releasedby an adutt-length
fingerby pushing
an internalcatch.
Doyou think these types are really elderly-accessible?
20 A group of scientists and techniciansare interestedin the productionand packagingfacilities at

your company.Discussthe visit on the phone.
Par tnerA ftl e 6, p.77
Par tnerB F !te5, p.79
87
UXiTG Pru.or iratEzgig B
Readthearticle.
@
B O YK I t t E D B Y P O T E N TPAIN PAT CH
A few yearsago,a motherwasconvictedof negligenceleadingto her son'sdeath.It

wasclaimedthat he had died from a pain medicationoverdose.Nowthe womanhas
taken measuresto ensurethat other childrendo not die the sameway.
sonlater found it and stuck it onto his leg,

just the way he had seenhis motherdo it.
The authorities becameinterested in
this case.The boy's death hightighted a
problemthat no one had anticipatedup to
that time. Becauseof her sont death, the
young motherdemandedthat safe-disposal
boxes be inctuded in the packagesof
medicated patches. These boxes should
havea smaltslit at the top to discardused
patches and it shoutd be impossibleto
A four-year-oldboy wasfound deadafter he openthem.
had stuck a highty potent, pain-relieving In the meantime, many medications,
patch to his teg. His motherwassentenced especialtythosethat involve needles,come
to several years' community serviceJor with disposatboxes for discardingthem.
teaving a used patch in a place ivhere her However,besides a warning about the
young son could have accessto it. The effectsof the medication,authoritieshave
patches had been prescribedfor her as unfortunately not madethe reguirements
treatment for a seriousintestinal disorder. regarding the disposal of potentially
She claimed that she atwaysput her dangerous materials any stricter.
used patches into an empty soda can, Fortunatety,though, many pharmaceutical
wheneverpossible.One day, however,she companieshave recognizedthe problem
did not have one available,so she put the and now supply boxes for disposalwith
used patch directly into the garbage.Her their products.
Whodo youthinkis responsible for the boy'sdeath?Themother?Thepharmaceutical company?

Someone else?
a Doyou knowof anysimilarcasesinvolvingpharmaceuticaI products?
a Pharmaceuticalcompanies are required to packagetheirproducts
in a childproof,
but elderly-
way.Whyis this so difficult?
accessible
88
a) A lot of people I know really believe in ghosts.

b) Martin grew to be very fond his pet snake.
c) This bread tastes fish!
d) Everyone was shocked Susan's strange appearance.
e) The company blamed the drop in sales the economic situation.
f) Brenda decided to discuss her problems a psychiatrist.
g) When Harry made his speech, everyone laughed him.
h) Robert has been married Deborah for over a year.
i) You were right after all the result of the election.
j) The woman who lived next door admitted the robbery.
2 Rewrite each sentence beginning as shown. Do not change the meaning.
a) Two men stole the old lady's handbag.

The old lady was robbed of her handbag,
b) John finds photography interesting.
John is
c) Helen has a good knowledge of car engines.
Helen knows a lot
d) The food in France is famous.
France is
e) I'd like to thank your brother for his help.
I am very grateful
f) Can you and Stephen share this book, please?
Can you share this book
g) I find studying all night rather difficult.
I'm not used to
h) Harry feels frightened when he sees a snake.
Harry is afraid
i) I'm sorry about breaking your camera.
Please forgive me
j) Peter knows how to draw well.
Peter is good
89
G R A M M A R 29 VERB/ADJECTIVE + PREPOSITION
a) David was .ashamed... of what he had done, and he blushed.

b) I'm not very on the idea of going climbing.
c) Mary is always about all the famous people she has met.
d) Jim was often for work, and lost his job as a result.
e) There were no empty seats on the train, which was of soldiers.
f) Bill decided not to Bob with his secrets.
g) The two boys were of stealing a sports car.
h) We in persuading Carol to lend us her boat.
i) You have worked very hard! I am very with you!
j) I can't remember her name, but it with 'J'.
a) William could do better work.

capable
William is capable of doing better work.
b) I own this car.
belongs
This car me.
c) The job received over a hundred applications.
applied
Over a hundred people the job.
d) Mrs Jones' death was caused by old age.
died
Mrs Jones old age.
e) 'Well done, Tony, you have passed the exam,' said Joe.
congratulated
Joe the exam.
f) Jean borrowed Shirley's camera.
lent
Shirley camera.
g) Graham found the film very boring.
by
Graham the film.
h) We all pitied Stephen.
sorry
We all Stephen.
173
90
a) My boss shouted at me - he was really angry. with me!

b) I can see your point, but I just don't with you.
c) Terry doesn't of his children going to rock concerts.
d) George and I about politics all night!
e) Can I have a at the evening paper?
f) This story me of a novel by Dickens.
g) Peter feels of anyone who talks to his girlfriend.
h) I didn't expect you to behave like that! I'm at you!
i) Oh dear, I forgot to any baking powder to the cake.
j) I think you should your boss for a rise.
a) Thank you very much. It's very B. you to help me.

A) good with B) good of C) good for D) good about
b) The bad weather was the series of power cuts.
A) blamed for B) blamed on C) blamed with D) blamed by
c) I'm sorry, but I seeing the manager at once!
A) arrange for B) look for C) agree with D) insist on
d) Why do you spend all your time your sister!
A) arguing about B) arguing for C) arguing with D) arguing at
e) Helen is very going to work in Germany.
A) excited about B) excited for C) excited with D) excited to
f) The tourists were not the danger of bandits in the hills.
A) known about B) aware of C) provided with D) guessed at
g) I understood the problem after it had been me.
A) explained to B) admitted to C) confessed to D) replied to
h) I wish you wouldn't show off and your success so much!
A) full of B) bored by C) boast about D) congratulate on
i) If you listen to music, you can't your homework.
A) read about B) arrange for C) specialise in D) concentrate on
j) Will we be the storm if we shelter under a tree?
A) happy about B) safe from C) depended on D) cared for
174
91
741
UNIT 7
Test yourself!
See how muchvocabulary you have learned. Use the ctues to complete the crosswordpuzzle.
Across
5 A taskperformed to fix something wrong.
5 A condition in whicha partof the body becomes red,warm,andswollen.
7 A placewherea companyhasits officesand/orfactories.
8 An unwanted medicaI occurrence duringa clinicaltrial.
7t Paperwork necessary to provideevidence or proof.
t2 A carefulstudyof a substance donebeforemedicineis developed.
74 A writtendescription of changes to a studyor trial protocol.
r8 Togiveor handin, e.g.a documentation to an authorityto obtainauthorization.
zz AnAmerican drugauthority.
27 Following rulesand regulations madeby peoplein authority.
z9 Ioput a coverovertablets.
3t A writtennotefroma doctorfor medicine.
33 Equipment usedto lift something.
34 the practice of makingsurethat goodsandservic'es fulfildefinedstandards.
35 Trialsto testa drugin humans.
36 A taskperformed to stopsomething badfromhappening.
Down
7 An examination of processes, procedures, andstandards.
2 Medicine provided by a chemistor pharmacist withouta prescription.
3 A mechanism whichreleases its contentsin definedamounts.
4 A mechanism or piece of equipment designed to performa special
function.
9 A difference from a specification,not withinthe accepted range.
10 Monitoring or evaluating suspected sideeffects.
73 A fixedworkingmethod,oftenwrittendown.
75 A substance recentlydeveloped.
16 Theabitityof a drugto treatthe illnessfor whichit wasdeveloped.
t7 An information sheetexplaining howto takea drug.
t9 Givingoff smallbubblesof gaswhenaddedto liquids.
20 Permission to sellanddistributea newdrug.
27 A persontrainedto do testson drugingredients.
23 Medicineobtainedin retailoutletswithouta prescription.
24 Features or characteristics ofa drug.
z5 A person whoagrees to participate
in a clinicaltrial.
z6 A typeof medicine, e.g.tablets,powder,ge[,spray.
z8 A substance in a drug.
3o A sma[[ animal usedas a subjectin the earlierstagesof preclinical
trials,e.g.mouseor rat.
3z A prescribed amountof a medicine or drug.
92
Testyoursetfl | 75
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*. rl.':l _*...,r,*i-**f-.--l
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93
76 1
Partner Files
YouareSarahManders. Youarea scientist

workingon an NCE.
Youneedto
decidewhatdosageformofa newdrugshouldbe
Hereis somebiographicalinformation:
developed.
Youarefairlyopento suggestions.
But
- Youworkas a productmanager in the Marketing
youalsohavesomeideasof yourownaboutcertain
department.
forms.
- Yourteamis responsiblefor the newproduct
underdevelopment. Youhavethe followinginformation:
- Youlivein London. - Thedrugwill costlessto developif it is madein a
- Youhavea degreein marketing. pill or tabletform,because the company already
- Youhaveexperience in marketing both hasthetechnology to maketheseforms.
prescription
andover-the-counter medications. - Sincethe activesubstance is in a concentrated
form,a patchmightbe a goodidea.Patches are
Taskr
easyto apply,nottoo expensive, andcanbe
CallRasheedPravda,
a newcolleaguefrom
ptacedrightat the pointof pain.
Affairs,whoyouwiltbe workingwith.
Regulatory
- Thebioavailability of the NCEwittbehighestin a
o Introduce yourself. capsuleformandcapsutes areeasyto swallow.
. TellRasheed something aboutyoureducational Therefore, youwouldfavourthisform.lf the
background, experience, andexpertise. clinicaltrialswith capsules aresuccessfu[, full
. Describe yourcurrentworkandyourrolein the production mightbe possiblein abouttwo anda
project. <+ ' halftothreeyearsfor European distribution.
. AskRasheed aboutthe statusofthe regulatory
Findout fromanotherscientist
whatdosageforms
documentation for the newproduct.
. Tel[himthatyouaregoingto a meetingwiththe he/sheprefersas painmedicationfor adults.
Giveyouropinionon whatdosageformshouldbe
marketing team.
r Promise develooed.
to givehiminformation aboutthe results
Agreeon oneformfor clinicaltesting.
later.
Afterwards,presentanyagreement you reachto the
Taskz restofthe group.
Rasheed callsyou back.Hereportsbackthe
Pravda
decisions
madeby the department.
Askhimwho is to preparethe medical
documentation, andwhenthe deadlinefor Youarean internalauditor.
preparation
of the formsis. Findout aboutthe standardoperating procedures
Herearethe actionpointswhichwereagreed: (SOPs) for all aspectsof safetyin the laboratory.
Askfotlow-up questions to ctarifyanyareasof non-
compliance.
Actionooints: lf therearenon-compliant areas,discusstheseat
. Sarah Mandere is to aek Raeheed the end.
?ravdaabout'a 7oseibledate for Usethe followingpoints:
marketinq aut'horizalion. r Askaboutthe clothingandsafetyequipment used
. 1arah Manders is to lead a taam in the lab.
of tw o ma rketinOaesi,trantg lo z Askwhatthe labtechnician woulddo if hazardous
preparelor launch. or toxicchemicalswerespilledon his/herlab
. Markefinq i5 to 6et rhe actual coat.
launchdate. lnformation f rom 3 Askwhatprocedures mustbe followedwhen
Re6ulatory Afraire must' be conducting experiments.
oWainedfirst. 4 Findout aboutthe proceduresfor the transportof
. Jahn Carlton ie to checkthe l abani mal s.
doc umenlar.ion to r marketrin4. 5 Findout howthe labtechniciandisposes oftoxic
wastematerials.
94
Files Tf
Partner
Reportbackto the groupanyareasof non- Makea noteof the implications

for the drugandfor
compliance
thatwereidentified. yourcompany.
Whatwasagreedin orderto achievecompliance
in
future?
You are responsiblefor organizingthe visit of a

group of specialiststo your companynext month.
Systematic testing Thedrugsubstance Ca[[your businesspartner regardingthe

donein animals that hasthe capacity arrangements.Discussthe followingpoints:
beforehumansare to havea
allowedto receivea pharmacological
substance. effect. - How tmanyvi"titors?
prectlnlcaltrials actlvepharmaceutical - Outline thz conpany tour (w ileriLe areas)
ingredlent - Ofer to rh4yt trainirV cedre - if requz:ted
- ltl,ewton con7qny riles (dos anl dowts)
Thequantities and A typeof smallanimal - Cor{trm mezlivg v,lith hand of pro/urti.ott,
combinations of usedin preclinical after luwh
differentsubstances trials,suchas mice
usedto make and rats.
medicine.
rodent
formulation
orquestions
Addanyotherinformation youthink
A personwho receives Therightgivenby necessary.
an investigational authoritiesto begiil
drugor a placeboin a with clinicaltestingin Tryto findcompromises.
clinicaltrial. humans.
subiect / volunteer permission
A periodof timespent A formalwordfora *'

doingpractical changemadeioa trial
trainingin a company. protocol.
internship amendment
Youarea drugsafetyspecialist.
A patientcallsyou.Findout the following
information:
. fu[[name,age,address, attendingphysician
o nameof all drugstaken,periodof time,dosage
. descriptionof symptoms, periodof time
. medicalhistory,anymajordisorders.
Askthe patientto consulttheirdoctorif theyhave
notyetdoneso.
Suggestthe patientmightneeddifferent
medication.
Informthe patientthatthiswill be reportedto the
if youthinkan adverseeventhas
authorities
occurreo.
95
78 1
Partner Files
Youare RasheedPravda. Youarea scientistworkingon an NCE.Youhavevery

strongopinionsabouteffectivedosageformsfor
Hereis somebiographical information:
painrelief.Usingthe foltowinginformation,present
- Youwork in Regulatory Affairs.
argumentsin favourofyour preferreddosage
- Youaregoingto leada teamresponsible for the
form(s).
marketingauthorization of a newproduct.
- Youareoriginally fromIndia,but havelivedin - Thecompanyis alreadysuccessfulwith its tablets
Switzerlandfor abouteightyears. andsuppositories youarestrongly
andtherefore
- Youhavea master'sdegreein pharmacyfrom in favourof theseforms.
AstonUniversity in Birmingham, England. - However, you will havethe technologyto make
- Youhaveexperience in preparing the dropsandsyrupsin a year.Theseformsarea
documentation necessary to obtainmarketing goodsubstitutefor peoplewho cannotswallow
authorizationin Europe. solidoralforms.Theywouldbe yoursecond
choiceas a dosageformfor the treatment of pain.
Taskr
- Thecompany doesnot havethe technology to
SarahManders,
a newcolleague
fromthe Marketing
producepatches.Youhavereadthat it canbe
witlcallyou.
department,
complicated to disposeofusedpatches, andthat
. Introduce yourself. theyarehighlytoxicfor childrenor animals.
. TellSarahsomething aboutyoureducational - Youcurrently producesuppositories,ointments,
background, experience, and expertise. ' andcreamsin a joint-venture proiectwith a
. Describe yourrolein the proiect. Japanese firm.lf youchoosesuppositories as the
. Tel[heryou havea meetingwith yourbossand dosageform,you couldworkwith yourioint-
newdepartment tomorrow. venturepartneragain,andtravelto Japan.
r Promise to cal[Sarahbackwith moreinformation. Productionmightbe possiblein a year-and-a-half
to two years.
Note:Youdo not knowthe currentstatusof the
regulatory
documents. Findout fromanotherscientistwhatdosageforms
he/sheprefersas painmedicationfor adults.
Taskz
Giveyouropinionon whatdosageformshouldbe
Youhavebeento a meetingwithyourbossandyour
developed.
newteam.CatlSarahbackto informherof the
Agreeon oneformfor clinicaltesting.
results,andaskherfor an updateon the marketing
Afterwards,presentanyagreementyou reachto the
authorization
andlaunchdate.
restofthe group.
Theactionpointsdecidedat the meetingare:
Action?oints: Youarea laboratory

technician.
. ManuelaFrit z is t'o ?re?arc Answerthe questionswhichyourcompany's internal

auditorasksyouaboutthe standard operating
medical d ocumentation fi procedures(SOPs)for safetyin the laboratory.
15 M a rc h .
, Margit Antnn is tn prepareall lf therearenon-compliant
areas,discussthesewith
the auditorat the end.
forms neededlor doasier VY
lOApril. Usethe followingpoints:
. Faaheedis t o co-ordinatn r Animalsmustbe transported
in disposable
cardboardboxesandas quicklyas possible.
ev eryt hingoo lh at th e dossier z Namethe usuallaboratory
clothingand
can be submitoedbYMaY5n . equipment.
96
PartnerFiles 79
3 Contaminated laboratoryclothingmustbe
removed immediately. Explain
howdirectskin Youarea patient.
contactcanbe avoided (seeexercisery for help).
4 Specialcontainers areprovidedfor the disposalof Readthe patientinformationleaflet.
toxicwastematerials. Namesomekindsof
materialsthesecontainerscouldbe madeout of.
Sayhowthe containers canbe recognized. Possiblesideeffucts
5 Onlythe resultsof experimentsaredocumented. Common sideeffects
of CAREFREEDO
ore:
Thisdoesnot necessarilvhaveto be done . nouseo
immediately. o vomiting
r obdominolpoin (poin in your slomoch
Reportbackto the groupanyareasof non-
or intestines!.
thatwereidentified.
compliance
Whatwasagreedin orderto achievecompliance
in In rore coses,the followingmoy occur:
future? o dizziness
r ollergicreoctions(for exomple,o rosh)
r elevotedblood oressure.
Furlherinformofion
A pharmaceutical Systematictestingof Coll 0041 303889222
formofan active a drugin humansto
ingredientwhichis determineits
Youhavebeentakingthismedication for two weeks.
testedin a clinical pharmacological
Sincethenyou havebegunto feeldizzy.Yesterday
trial. effectivenessand
youactuallyfaintedandweretakento hospitat. You
safety.
investigationaldrug wereableto leaveafterfive hours.
ctlnicattriat Youhavea historyof dizziness wheneverthe
weatherchanges. At the momentthe weatheris
Theamountofa drug Recordsof a trial, stable.Youalsohavehayfeverand areallergicto
administered to an includinginformation severalpollens.Thisis the reasonyou takethis
animal,heatthy on dosages,methods, medication.Youthinkthatyourfaintingand
volunteer,or patient. results,factors,and dizzinessarea resultoftakingthisdrug.
actionstaken. Callthe pharmaceutical company anddescribe your
dosage situation.
documentatioo -
Theactionof giving A simulatedauditto

someone a drug. preparefor an
a visitto yourbusiness
Youareorganizing partner's
inspectionby companynextmonthfor a groupof specialists.
administration
regulatoryauthorities.
Yourpartnercallsyou.
mockinspection
Usethe followingnotesto clarifya fewdetails:
Theshortformof a A personwho
- Cor/i* sizz ofgroup (l)
signatureusingthe performstestsin a
- Qo two stertJc otrea?
first lettersof your biotogyor chemistry
name. laboratory. - Luwh with Head of productwd
- Vkit pack4givEarea?
lnitials lab technician
.-="=-
.:".:..====: =...- . J
Addanyotherquestions
you mayhave.
Tryto find compromises.
97
s4 l
Useful phrases
Themainreason... Beforeweclose,I'dliketo review...

Hereis an updateon theproject. Firstof atl,...
Asyouknow,... ...is to finishworkbytheendof the month.
Youareprobably awarethat... ...will be lookingafterthe...
Asfaras...is concerned,
... ...is goingto find...
Finatly,...
Eachdepartment needsto getbackto meby...
This...isto advise...that...
The...wiltbereviewed...
Ourgoalis to ... Wetcomingthe audience
...department is scheduled for... [adiesandgentlemen.
Goodmorning/afternoon,
The...isasfollows: ... I'mhappyto welcomeyouto ourcompany.
Pleasemakesurethat...
Please sendus... Introducingyour topic
Please confirm... Letmegiveyou a briefoverviewof ...
I'mhereto giveyousomeinformation on ...
Today,I'llbetalkingabout...
Signposting
Askingfor andclarifyinginformation Movingon to the nextpoint,...
Couldsomebody fitlmein on ...? As I mentioned earlier,...
I'dtiketo knowwhathashappened. Comingbackto ...
Doesthatmean-..? Letmecomebackto whatI saidbefore...
I haveheard.... ls thatcorrect? Addingpoints
Makingsuggestions Inadditionto this,...
I suggest
making... Moreover/Furthermore, ...
I suggest
wetake... Apartfiomthis,...
Wecouldconsider trying... Dealingwith intenuptions
So,we'dbettertest ... CouldI pleasefinishwhatI wassaying?
Responding to sutgestions lf I couldiustfinishwhatI wassaying...
I'tlletyouknowwhatwecomeup with. Dealingwithquestions
I'mnotsureI agreewithyouon that. Therewiltbetimefor questions aftermytalk.
Feelfreeto askquestions aswego along.
lfyouwouldliketo askanything, go ahead.
Askingfor opinions Finishing
Whatdo youthink...? Finally,
I wouldliketo add...
What'syouropinionon ...? Asa finalpoint,I wouldliketo say...
What'syourviewof ...? Torecap,...
Avoiding/t{ithholdingopinions I hopethishasgivenyouan ideaabout...
I wouldrathernotsay...
I'msorry| cannotcomment on ...
I'mafraidI amnotin a positionto answerthat. Certain points,or
wordsareaddedto makeadditional
Givingopinions to compare
or contrastideas.
I think/lfeel... Addinga relevantpoint
In myopinion, ... Inaddition,/Additionatty, ...
Frommypointof view,... ...notonly..., butalso...
Givingstrongopinions Besides,...
| firmlybelieve... Furthermore,...
I feelverystronglythat... Xlakinga comparison or a contrast
I'msure/certain/convinced ... ..., whereas...
...,while
...(even)though
However, .../But...
98
UsefutohrasesI 95
Thepassiveis oftenusedto describea process. it focuseson theaction,ratherthanon the personor

Weuseit because
thing(agent)doingtheaction.Oftentheagentis unclear,
unknown,or irrelevant.
Anexperiment carriedout/conducted/done/performed.
A trial/study
is/was
A drug absorbed/administered/formulated/
manufactured
/
prescribed
/taken.
Thedata provided/transm
itted.
are/were
A numberof experiments conducted/done/performed.
Several
tests
Thecriteria can met.

must be
A study will carriedout/cond
ucted/done/performed.
Thepassive Forthis,by + ogentis added.

canalsobe usedwhentheagentis knownor relevant.
Themoisture is removed bythe hotair in thefluidbeddryer.
Thegranules are transported bythe hoist.
Wewillneeda bit moretimeto completely answerthatquestion.

Wearestillrunningteststo findoutwhatkinilsof sideeffectsarepossible.
Wecangiveyouthe answerrn aboutfour weeks.
lt wilttakefromobout sixmonthsto a yearanda half.
Notyet!Butweteworkingon it.
Talkingtostaff
Dosage Whatisyourname?
Whatkindof formutationcouldwedevelop? Whatisyourjob?
Whataboutusingotherforms? Whatisyoursupervisor's
name?
or dropspossibte?
Aretablets,capsules, Whatisyoursupervisor's
lob?
Whataboutthe dosagefor theseforms? Askingaboutprocessesand procedures
Development Howhaveyoubeentrained to perform
thisprocedure?
Whatis thetoxicityof thisNCE? Howmuchtimedoesit taketo complete thispartof the
Whataboutthebioavailability of this NcE? process?
Whencanwestartthefirstin-manstudy? Whatspecial procedures
mustbefollowed in a
Dowe havethetechnology to makepatches? laboratory?
Whatspecial procedures
mustbefoltowed forthis
process?
Askingaboutpossibleactionstaken
Givinginformationat inspections Howdo youhandletoxicwastein the lab?
Herearethedocuments yourequested. Howdoyouhandle thetransportation of animals
in the
I'll getit immediately. lab?
Youcanfindthison pagethree. Whatwouldyoudo ifyou gota toxicsubstanceon your
Thechange out,initialled,
is crossed anddated. labcoat?
Letmeexplainin moredetail... Whatwouldyoudo if younoticed non-compliancewith
I cangiveyoumorespecificinformation on ... safetyprocedures
bya colleague?
Explainingandiustifyingdecisions
Letmedemonstrate...
Wehadno alternative butto ...
I assureyou...
Youcanrestassured thatwewill ...
Thatledto...
Thisway,youcan/willavoid...
99
s6 l Usefulphrases
ileutral
I suggestyouput'Notoxicwaste'onthebin. Pharmaceutical companiesusedetailsfromdoctors'
Mysuggestion is thatweredotheequipment list. in a casereport.
reportsto informtheauthorities
Myrecommendation is to tatkto thelabworkers.
Patienthistory
It mightbepossibleto relocate theequipment.
Thepatienthasa historyof...
Sttong A reportwasreceivedfromthephysician indicating
Theontysolution is to rethinktheprocess. that...
I stronglysuggest thatwetry to prevent it in future. Beforetheevent,the patientwason thefollowing
I'mconvinced we mustrepeat thelasttests. ...
medication:
It is absolutely
essential to learnthesafetyrules.
Descriptionof adverseevent
Afterexamining thepatient,thephysician
...
Aftertaking(drug),the patientexperienced
...
At thetimeof thereport,thepatient's
condition
Requestinginformation was/remained unchanged.
Please the procedure
describe forthe ...process. At thetimeof thereport,thepatientwas
Wouldyoupleaseclarifyhowyou...? recovering/hadcompletely recovered.
Coutd youexplaintheprocedure forthedocumentation Thiseventledto the patient's
death.
of ...?
Druginformatlon
Askingquestions ...areknown/suspected
sideeffectsofthis drug.
Whataretheguidelines for...? (Drug)wasadministeredfor {condition).
Howoftendo youhaveto...? Eyedropswereinstilled.
Whatspecialprocedures do youfollowfor...? wasapplied
A bandage/cream/lotion/ointment (tothe
Howwouldyouensuregoodhygienein the laboratory? skin).
FormulatingSOPguidelines Assessment of adverseevent
Properprotective clothingandsafetyequipment must (Drug)is (not)believed
to be relatedto theevent.
be wornat all times. An interactionbetween(drugx) and(drugy) was
Propersafetyprocedures mustbe caniedout by.* Susoectecl.
laboratorystaff. between(drug)and(symptom)
A correlation can/
Toxicor hazardous materialsmustbe disposedof cannotberuledout,
properly.
Note:SOPsoftenusethefollowingstructure:
mustol
shouldbe +verb It coutdhavebeendueto...
It is dueto pre-existing
conditions.
Theevidence is conclusive/inconclusive.
lf yougiveinstructions A reaction to theproduct cannotberuledout.
in a verydirectway,it may
soundimpolite. Therefore, to watchyour
it is important
toneof voice,andhowyouphraseyourinstructions.
Howdidtheclinical trialsgo?
Notethatwhenyoutellpeopleto do something
Whatis the statusof approval?
mandatory if youadda simple'please', your
it makes
Howfar is it fromapproval?
instructions
soundmuchnicer.
Couldit ieopardizeotherproducts?
e.g.Pleoserememberthat theovershoesareonly Whatdoesit meanfor the productsin the pipetine?
allowedto touchthe whiteorea.
Notethat'mustn't'means thatyouarenotallowed
to
do something. Mensomintrt moycausedizziness.
Mensomintrtconinteractwithothermedicines.
e.g.Theremustn'tbe morethanthreepeoplein the
gowningroomat a time. Likeall drugs,thismedicinecancausesideeffects.
UseMensomintrtwith cautionwhiledrivingor
Politeinstructions undertaking activities.
dangerous
Couldyouplease... ? It is possiblethatyoumayreceivethismedicine,
or an
Wouldyouplease... ? alternativemaybe used.
Please makesurethat...
Pleaseremember/Don't forget...
Please keeoin mind...
l/Weneedyouto... Donot use/takeMensamintru if ...
Stopuseandaska doctorif ...
Keepout of reachof children.
Tellyourdoctorimmediately/right awayif ...
Youmustnot drivewhiletakingthisdrug.
YoushouldnottakeMensaminf rn if you have
a historyof ...
100
Unit 7
Put one suitable w o r d in each space.
Holiday problems
Somehow I always have problems when I go away on holiday. (1) every.
year my travel agent promises me that my holiday will be (2) best
I have ever had, but none of these promises has ever (3) true. This
year I got food poisoning (4) day I arrived. It must have been the
fish I ate at the hotel (5) evening. In (6) morning I
felt terrible, and I was seen by two doctors. I tried to explain my problem to
them, but (7) of them spoke English, (8) didn't
help. It took me (9) of the first week to recover, and I spent three
or four days sitting next to (10) hotel swimming pool reading
newspapers. By the time I felt better, (11) weather had changed,
but I was determined to go sight-seeing, and do (12) swimming.
Unfortunately (13) of the museums were open, as there was
(14) strike. I would have enjoyed myself (15) if I
had stayed at home.
a) That's the worst film I've ever seen.

worse
I've never seen a worse film.
b) There aren't any sandwiches left, I'm afraid.
all
I'm afraid eaten.
c) I thought that Martin's last novel was more interesting.
latest
Martin's interesting as his last one.
d) I talked to neither of Harry's sisters.
either
I didn't , Harry's sisters.
146
101
G R A M M A R 25 CONSOLIDATION 5
e) Bob is a much better swimmer than George.

swim
George as Bob.
f) If you walk slowly, it takes longer to get there.
longer
The more it takes to get there.
g) Calling the police isn't any good.
no
It's the police.
h) I phoned Norman last of all.
person
Norman phoned.
i) This is the best party I've ever been to.
a
I've good party as this.
j) I thought this meal would cost more than it did.
less
This meal thought.
3 Complete each sentence w i t h one suitable w o r d . Do not use the w o r d piece.
a) Would you like another slice. of cake?

b) There is another of stairs after this one.
c) What a lovely of hair you have.
d) Put up your hand if you need another of paper.
e) There was an interesting of news about Japan in the paper.
f) Could you put a few of coal on the fire?
g) Pour me a of water, would you?
h) They gave me a very large of potatoes with my dinner.
i) There was a terrible flash of lightning and a of thunder.
j) Oh bother, I've split my new of shorts.
147
102
4 Rewrite each sentence so that it contains the w o r d given in capitals, and the
meaning stays the same. The w o r d cannot be changed in any way.
a) You are not allowed to park here. PARKING

Parking is not allowed here,
b) There aren't any tables, chairs or beds in the house. FURNITURE
c) This room seems very crowded. PEOPLE
d) Can you tell me about guided tours of the city? INFORMATION
e) The people in the theatre were enthusiastic. AUDIENCE
f) I like maths best. SUBJECT
g) There are a lot of cars on this road today. TRAFFIC
a) Jim teaches French.

works
Jim works as a French teacher.
b) Can't you do better than that?
the
Is do?
c) I haven't eaten lobster before.
ever
This is the eaten.
d) Is Julia a good violinist?
play
Can Julia well?
e) Actually, the only thing you need is a screwdriver.
all
Actually a screwdriver.
f) Both of the lifts were out of order.
of
Neither working.
148
103

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“Ovidius” University of Constanţa

STEPS FOR PARAPHRASING

EXAMPLE OF CORRECTLY PARAPHRASED INFORMATION

ORIGINAL TEXT ACCEPTABLE PARAPHRASED TEXT

ASSESS YOUR PARAPHRASE

 The MEANING is the same.

STEPS FOR SUMMARISING

EXAMPLE OF CORRECTLY SUMMARISED INFORMATION

ORIGINAL TEXT ACCEPTABLE SUMMARISED TEXT

ASSESS YOUR SUMMARY

Underline the most suitable w o r d in each sentence.

a) Different countries have different weather/weathers.

2 Complete each sentence w i t h a/an, some or by leaving the space blank.

a) When the play ended, there was / lengthy applause.

3 Underline the most suitable w o r d in each sentence.

a) I would love to go on a long journey/travel by train.

4 Put one suitable w o r d in each space.

a) I'm looking for .accomodation . Do you know anywhere I can stay?

5 Complete each sentence w i t h the most suitable w o r d or phrase.

a) I like your new trousers. Where did you buy B ?

6 Choose the most appropriate meaning for each sentence.

a) You mustn't lose heart.

a) This island has a large population.

f) There are pieces of paper all over the floor!

8 Complete each sentence w i t h a suitable w o r d f r o m the box.

a) Let me give you a piece of advice.

9 Complete each sentence w i t h a suitable w o r d f r o m the box.

a) I can't cut this loaf. Do you have a proper bread knife?

10 Decide which answer (A, B, C or D) best fits each space.

1) A times B meals C foods D plates

Key points 1 Check in a dictionary to be sure that a noun is countable or uncountable.

Substance discovery and product development

Research- the processof testingchemicaI withthe goalof findinga substance

- the processof carryingforwardscientific

$lhet klndsof R& D prdectr arethereln yourcornpanyat the noncnt?

18 I UNIT2 Substance andproductdevelopment

t Readthe memo and the information about filensamintil.

As someof you will alreadyknow, a new chemicalentity hasjust

A meetingwill be held tomorrow at 9.30a.m.in conference room 308

Answer the folloring questions.

r Whatis the meetingabout,andwhatneedsto be discussed?

Whatkindof productis Mensamintru?

3 Whatdo patientshaveto do to obtainit?

Wewilt haveto testthe bioavailability

Notcompletely. However, we do havea partnerto helpus developa patchformwhichprovides

I'mafraidit maytakea yearor morebeforewe canstartthe firsttestson healthvhumans.

3 Putthe correctformof oneof thevocabulary

thiswordis alsousedfor the personwhoprepares

z Usingthe right is especially whengivingmedicine

5 Beforedrugsor medicines to the public,theyhaveto be testedon human

4 A fewdayslater,the participantsreceivedthe minutesof the meeting.Listenagainto exercisez

C l) fhen Marcus brought up the subjectof the NCE's toxicity'

t I ,Lfter that, Frank askedabout the bioavailabilityof the new chemicalentity.

The meetingfinishedat 10.30a.m.The next PHARilACOKI

r fJ fhe side-effects for the productis not finishedyet.

z [_l Thereareotherdosageformswhichworkbetterthanthe patchform.

3 n lt witlontytakea few monthsto furtherdevelopthe patchform.

; Wewitlneeda bit moretimeto completely answerthatquestion.

6 Putthewordsin the right ordertb makequestionsandanswersaboutsubstance

z about forms What the. dosage?

Answerz answeryet don't haveWe a completeto questionthat

3 NCEthis is What toxicityof the ?

4 can study the Whenwe in-manstart first ?

Question5are What effectskinds possibleof side ?