BIOPHARMACY

Contents

1. Simple Choice ............................................................................................................................. 2

2. Multiple Choice........................................................................................................................... 9
3. Associations .............................................................................................................................. 16
4. Relation Analysis ...................................................................................................................... 25
5. Calculations............................................................................................................................... 29
6. Answer key................................................................................................................................ 34

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1 . S im p le C h o ic e

Please, choose the correct one (only one) from the answers below each question.

1. Probenecid lengthens the duration of penicillins effect because

A) it blocks its metabolism

B) it pushes out penicillin from the silent binding sites
C) capacity of tubular excretion is distributed between the two substances
D) it promotes penicillins absorption
E) it blocks penicillins accumulation in the peripheral compartments

2. Bioavailability is the

A) duration of drugs therapeutic blood level

B) most proper drug administration
C) drugs quantity and velocity of absorption from the preparation
D) pharmacons effectiveness in the body
E) pharmacons affinity to its receptor

3. In pharmacokinetics, what does smooth tissue mean?

A) rich in water
B) hardly accessible for pharmacon
C) deformable mechanically
D) mostly accessible for pharmacon
E) bone tissue

4. Which digitaloid has the best bioavailability after per os intake?

A) digitoxin
B) acetyldigitoxin
C) digoxin
D) lanatoside C
E) vinpocetine

5. Choose the right tetracycline derivative the dosage of which does not need to be
decreased even in case of a reduced kidney function.

A) vancomycin
B) amikacin
C) gentamicin
D) oxytetracycline
E) doxycycline

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6. Which statement characterize the intravenous administration ?

A) microcrystal suspension can also be used

B) overdose can not be corrected
C) solutions that are not pH 7.4 should not be injected
D) it is also suitable to produce a local effect, too
E) only lesser than 10 milliliters of intake volume should be applied

7. What does first pass effect mean?

A) the pharmacon after its absorption from the gut arrives primarily at the systemic
circuit avoiding liver
B) the pharmacon after its absorption from the gut is metabolised in the liver during its
first pass
C) it has the fastest effect
D) the pharmacon after its absorption from the gut is excreted primarily with the bile
E) pharmacons that can pass the blood-brain barrier have mainly central effect

8. Which heart glicoside binds to plasma proteins the least?

A) acetyldigitoxin
B) digoxin
C) digitoxin
D) lanatoside C
E) ouabain (G-strophanthin)

9. How do you explain the quick end of the intravenous thiopentals effect?

A) it is because of the redistribution by which this substance is being stored in the

depo fat
B) the substance is insignificantly lipophilic
C) the substance is eliminated quickly through the lungs
D) it is metabolised quickly in the skeletal muscle
E) it is cleared quickly by the kidneys

10. Which substance does not typically have an enzyme inductor effect?

A) androgenes
B) spironolactones
C) aminoglicosides
D) glucocorticoids
E) barbiturates

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11. What does pharmacokinetical compartment mean?

A) part of the body water which is located in the vascular system

B) total body water (TBW)
C) plasma and intracellular fluid together
D) part of the body water in which the change of a particular pharmacons
concentration has the same kinetics
E) anatomical water compartments

12. What is lag time?

A) the duration hat is needed by the pharmacon to reach the lower level of therapeutic
blood level
B) the duration that is needed by the pharmacon to reach the maximum effect after
intake
C) the duration that is needed by the pharmacon to get measurable in the blood
D) the duration that is needed by the pharmacological answer to take place
E) the duration while the concentration reach its plateau

13. Which statement is incorrect?

A) iron preparations can block the absorption of tetracyclines

B) enzyme induction can provoke lethal drug intoxication
C) as an effect of a long-term medicine intake the metabolism of endogenous
substances can be disturbed
D) drugs that have acidic pH can block each others renal excretion
E) only those drugs have long pharmacological effect that can bind to plasma proteins
well

14. Which statement is correct?

A) enzyme induction may be neglected when calculating the right therapeutic dose
B) the enzymes that are not metabolised on microsomal level can not be induced by
pharmacons
C) microsomal enzyme system can not be inhibited
D) metabolites of drug always have smaller pharmacological effect than the original
drugs
E) therapeutic dose should always be corrected when deviation from average body
mass (70 kgs) is significant (+40 kgs)

15. The duration which is needed to reach the 95 per cent of the plateau:

A) five times as long as the elimination half life

B) five times as long as the absorption half life
C) five times as long as the adsorption half life
D) twice as long as the absorption half life
E) twice as long as the elimination half life

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16. What is the meaning of "disposition"?

A) decreasing of active ingredient in the central compartment due to distribution

and/or metabolism, elimination
B) liberation and distribution of active ingredient in central compartment
C) distribution of active ingredient and metabolites between central and periferal
compartment
D) elimination of active ingredient by distribution and excretion
E) storage of active ingredient in a depot phase, and its proteine binding, respectively

17. What is the meaning of plasma clearance?

A) Percent of drug clears up from plasma in unit time.

B) Volume of plasma clears up from active substance in unit time.
C) Hypothetic plasma volume, which clears up from unmetabolised active substance in
unit time by any of the elimination processes.
D) Volume of plasma clears up from drug in one minute passing through the liver.
E) Volume of plasma clears up in unit time from drug excreted by the kidney.

18. Basic pharmacokinetic parameters (ke, t1/2) calculated from urinary data may substitute
data calculated from plasma, if

A) Minimum 95 percent of drug excreted via the urine, no metabolism, no protein

binding, no storage, no enterohepatic recirculation.
B) The drug excreted unchanged form 100 percent via the urine.
C) Value of renal clearance is minimum 100 ml/min, no tubular reabsorption and
metabolism.
D) Drug exreted minimum 90 percent via the urine, no metabolism, or known and
detectable is the metabolite, no protein binding, no storage, no tubular reabsorption.
E) Drug exreted minimum 90 percent via the urine, no enterohepatic recirculation, no
protein binding, no storage, no tubular reabsorption.

19. Which situation is given on the figure from single dose administration

A) intravascular administration with significant distribution

B) intracutan administration with metabolism
C) extravascular administration with rapid metabolism
D) intramuscular administration with excretion after metabolism
E) rapid intravascular administration, when the drug excreted mainly as metabolite

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20. The following is the part of a therapeutic system.

A) loop
B) coated pellets
C) drug release element
D) radiating energy
E) phospholipide membrane

21. Definition of therapeutic systems

A) Therapeutic system is a drug containing preparation liberating the active ingredient

with predicted rate and timeinterval into the systemic circulation and provide the
optimal plasma level "without fluctuation".
B) Therapeutic system is a preparation with sustained release, allowing to liberate the
drug according the requirements of body and prepared from bioerodible material.
C) Therapeutic system is a preparation acting systematically or locally and liberates the
drug by previously programmed rate determined according to the absorption
probability.
D) Therapeutic system is a preparation which liberates the active ingredient by zero
order kinetic both the initial and maintaining doses through a micropore membrane.
E) Therapeutic system provides the liberation of active ingredients with short
biological half life and narrow therapeutic range according to diurnal rhytm to make
safe the treatment.

22. Definition of bioavailability

A) Bioavailability is that drug ratio which exert therapeutic effect after liberating from
preparation at given timeinterval, absorbing and reaching the systemic circulation
given different way than iv. administration.
B) Bioavailability is defined as both the relative amount of drug from an administered
dosage form which enters the systemic circulation and the rate at which the drug
appears in the blood stream.
C) Bioavailability is that drug amount which exert therapeutic effect after reaching
systemic circulation given different way than iv. administration.
D) Bioavailability is a value of effectiveness which could be given us the amount of
active ingredient in body fluids or excreted amount or as a given pharmacological
effect.
E) Bioavailability is that timeinterval, when the plasma concentration is above a
determined limit and processes of absorption, elimination and metabolism is of first
rate.

23. Which data is needed to decide on that the drug is suitable to prepare retard preparation?

A) clearance
B) area under the curve
C) biological half life
D) absorption rate constant
E) "first-pass" effect

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24. Which method is not suitable to calculate area under the curve?

A) least square method

B) weighing
C) planimetry
D) trapezoid rule
E) integration of curve

25. Pro-pharmacon is a compound, which

A) gets active after reaching the site of action depending on the number and quality of
substituents on the molecule.
B) containing the active substance in an inactivated form, in bioreversible bound, but
reaching the site of action gets active according to the components.
C) contains the active substance in an inactivated form, due to reduced solubility
complexes, but reaching the site of action gets active according to the components.
D) contains the active substance in an inactivated form, due to chemical alteration,
changing the valance, but reaching the site of action gets active according to the
components.
E) contains NH-acid groups, but reaching the site of action gets active according to the
components.

26. Which are those therapeutic systems, which liberate the active ingredient through a
special hole, prepared by laser?

A) TTS patches
B) IUD systems
C) OCUSERT systems
D) OROS systems
E) flotating systems

27. Which factors has no effect on bioavailability?

A) the value of blood level us time curve (AUC)

B) maximum plasma level
C) therapeutic range
D) time to reach maximal plasma level
E) quality and quantity of food

28. What is the meaning of biological half life?

A) that time interval, during the half of the drug degrade in body
B) that time interval, during the amount of drug reduced to its half
C) that time interval, during only the half of the biological effect developed
D) that time interval, during the half of the drug metabolised
E) that time interval, during the half of the drug liberates from protein binding

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29. What is required to produce constant blood level, when the preparation contains initial
and maintenance doses

A) When the initial and maintenance doses liberate at the same time and the rate is
first order.
B) When the half of the particles is uncoated in the preparation.
C) When the initial and maintenance doses liberate with zero order kinetics.
D) When the initial dose liberates with first order and the maintenance dose liberates
with zero order kinetics.
E) When the active ingredient liberates with zero order and the maintenance dose starts
to liberate when the initial dose reaches its maximum.

30. Which are the basic conditions that provide the function of therapeutic systems?

A) Artificial materials ensure the function

B) It contains the active ingredient in solid form
C) Biodegradable polymer materials ensure the controlled release
D) It contains a regulatory unit and produces programmed liberation
E) The liberation of active ingredient is controlled by the transmission (pore size) of
the surface membrane

31. Which preparations has three dimensions?

A) prepared by spherical particles

B) which can be characterized by the amount of incorporated drug in definite volume
C) during their development the following three elements were evident: absorption
probability (Fabs), mean residence time (MRT), bioavailability (AUC),
D) applying on skin they exert penetrating, permeating and absorbing effect
E) which needs the time factor to be built into the preparation.

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2 . M u lt ip le C h o ic e

More than one from the answers below each question is correct so please use this alphabet
scheme to solve the test:

A): only the first answer is correct

B): only the third answer is correct
C): only the first and fifth answers are correct
D): only the second and third answers are correct
E): only the second and fourth answers are correct

32. Choose the right statement. Characteristics of pharmacons biliary excretion are:

1. its direction is the same as drugs concentration gradient

2. its direction can even be against drugs concentration gradient
3. it can be saturated by increasing the plasma concentration
4. chargeless molecules influence each others excretion
5. ions with the same polarity stimulate each others excretion

33. Which parameters are redundant for the calculations of maintenance dose if the drug
has Michaelis-Menten kinetics?

1. elimination half time

2. maximum velocity of pharmacons metabolism
3. average plasma concentration within a particular period
4. the plasma concentration by which the velocity of metabolism is half of the maximal
value
5. dosing interval

34. Which substances alkalize urine?

1. dimercaptopropanol
2. thiazide type diuretics
3. antacids
4. salicylates
5. spironolactone

35. Which statements are right if kinetic parameters of the applied drug are modified by
reduced renal function?

1. dose must be decreased

2. dosing interval must be decreased
3. half life can drop significantly
4. ratio of free and bound (to plasma proteins) molecules is not changed
5. renal clearance decreases

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36. Which statements are right? They relate to the substances that take part in the entero-
hepatic cycle.

1. some have biliary elimination in form of glucuronides

2. the cycle does not change the duration of effect
3. glucuronides are absorbed in the small intestine
4. benzodiazepines do not take part in the cycle
5. temporary increase of plasma concentration can be observed in the elimination
phase

37. Which substances will have therapeutic effect after oral intake?

1. streptomycin
2. quaternary ammonium bases
3. hemisynthetic penicillin derivatives
4. insulin
5. penicillin G

38. Which substances kinetics can be described using the one-compartment model?

1. oxytetracycline
2. theophylline
3. caffeine
4. chloroquine
5. digitoxin

39. Which factors change drug sensitivity in newborns?

1. relatively great amount of extracellular fluid

2. increased permeability in capillaries (blood-brain, blood-liquor barrier)
3. metabolic enzyme differences between adults and newborns
4. lack or immaturity of metabolic enzymes
5. gut motility is more intense than in adults

40. What kind of information does numerically described AUCT have?

1. pharmacons concentration at a given point of time

2. time needed by the pharmacon to get into the systemic circulation
3. the quantity of active compound that can get into the systemic circulation from the
preparation in a given time
4. duration while the pharmacon remains measurable in the body
5. tmax and Cmax values of the blood level curve

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41. What are the consequences of being bound to plasma proteins?

1. increases the concentration of pharmacon in biophase

2. forms a depo and can prolong the duration of drugs effect
3. it can be an origin of interactions
4. molecules bound to plasma proteins are also filtrated in glomeruli
5. pharmacon concentration of blood does not have an effect on its linkage to plasma
proteins

42. Select the right answers. Drug is metabolized

1. not only in liver.

2. only in liver.
3. only in kidneys.
4. only in liver and kidneys.
5. only in liver, kidneys and lungs.

43. Which statements are correct about lidocaine?

1. it is used in ventricular arrhythmia in most cases

2. elimination half life is 8 hours or more
3. it is used the least in ventricular arrhythmia
4. propranolol and cimetidine stimulate its metabolism
5. propranolol and cimetidine slows down its metabolism

44. Choose the right statements about procainamide.

1. its half life is 10-14 h

2. it is given orally as a prophylactic treatment
3. it can be used as a local anesthetic agent
4. its metabolite, N-acetyl-procainamide has the same antiarrhythmic effect as itself
5. it is inactivated in liver so there is no need to decrease dose in case of kidney
malfunction

45. Choose the right assertions about amphetamine.

1. it may be found unchanged in urine

2. intensity of its effect depends strongly on urines pH
3. urine should be acidized in acute amphetamine toxicosis
4. AUC values of the same doses are independent of the part of the day
5. metamphetamine (amphetamine derivative) has no effect

46. Which are the correct assertions about benzodiazepine?

1. very small amount is absorbed from gut so mostly intravenous intake is applied
2. binds hardly to serum proteins
3. its metabolite, N-methyl-diazepam is not as active as itself and acts as a partial
antagonist
4. average half life is 6-8 hours
5. redistribution is not characteristic to its movement in water compartments

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47. Which statements are true? Renal excretion of weak bases

1. can be decreased by the acidification of urine

2. can be sped up by the acidification of urine
3. can be stimulated by sodium bicarbonate
4. can not generally be changed by the substances that block active transport
5. can not be changed by the modification of urines pH

48. Which assertions are false?

1. simultaneous consumption of milk blocks the absorption of tetracyclines

2. eating slows down the absorption of digoxin
3. insulin is not absorbed from the large intestine
4. absorption of griseofulvin will be faster if it is consumed together with a fatty meal
5. insulin should be given parenterally otherwise it is digested by pepsin in stomach

49. Which statements describe the saturating dose? In case of a long-term intravenous
infusion, the saturating dose

1. is used when the pharmacon has long elimination half life

2. is applied to raise the level of a planned plateau
3. has no connection with the duration of time needed to reach the plateau
4. decreases the infusion rate that maintains the planned plateau
5. has to be at least ten times as much as the maintenance dose

50. Choose the false statements.

1. using the body surface for calculations of child dose is the most proper method
2. clearance of salicylic acid is 60 per cent greater in men than in women
3. most pharmacons elimination half time is longer in obese (fat) people
4. body mass dependent clearance increase and decrease of elimination half life happen
at the same time
5. duration of effect and toxicity changes with the period of day

51. What does A mean in the word LADME?

1. area under the curve

2. availability
3. absorption
4. accumulation
5. adsorption

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52. Which parameters determine the rate and extent of bioavailability?

1) value of area under curve (AUCt)

2) value of area under curve (AUC), maximal plasma concentration (Cmax, time to
reach maximal plasma concentration (tmax)
3) value of area under curve (AUC) and value of maximal plasma concentration
(cssmax) at steady state
4) hypothetical plasma concentration at time=0 (cp0), maximal plasma concentration
(Cmax) time to reach maximal plasma concentration (tmax), elimination rate constant
(kel)
5) total amount of unmetabolised active ingredient (Ae), absorption rate constant (ka),
elimination rate constant (kel)

53. Which physiological factors alter the onset of biological response?

1) body weight, age, gastric emptying time

2) ratio of protein, fat, carbohydrate in food
3) body surface, height
4) energy sources in body to be mobilise
5) genetic factors, state of kidney and liver, blood flow through organs

54. The biological half life of which drugs does not alter significantly in reduced kidney
function?

1) ampicilline
2) doxycycline
3) cefaclor
4) penicillin G
5) streptomycin

55. Which active ingredients have short biological half life?

1) cimetidine
2) cyclobarbitone
3) cefaclor
4) cycloserin
5) Vitamin C

56. Which in vitro models are suitable to determine the liberation of active ingredients?

1 ) rotating basket model

2) solvometer
3 ) disc model
5) paddle method

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57. What is the reference during calculation of absolute bioavailability?

1) BA of oral solution
2) BA of IV administration
3) drug product containing the active ingredient in the same dosage form and in the
same dose
4) the dose
5) drug product containing the same active ingredient, in the same dosage form and in
the same dose

58. Which analytical methods are the most sensitive ones in biopharmacy?

1) GC with flame-iorusation detector

2) GC with electroncapture detector
3) RIA
4) detection of total radioactivity
5) fluorimetry

59. The absorption of drug may be enhanced, when

1) the drug absorbs from the upper part of the colon

2) the drug absorbs from the stomach
3) the drug absorbs from the upper part of the jejunum
4) the drug absorbs from the lower part of the jejunum
5) the drug absorbs from the lower part of the colon

60. From which part of the GI tract sugars absorb?

1) jejunum
2) stomach
3) colon
4) rectum
5) oesophagus

61. Which factors has to be taken into consideration when dosage regimen is determined?

1) biological half life

2) volume of urine excreted
3) amount of metabolites excreted
4) absorbed amount of active ingredient
5) age

62. Which factors are negligible during dissolution test determined by rotating basket
method?

1) rotation speed of basket

2) the humidity and temperature of surrounding air
3) the place of sampling
4) the composition of dissolution medium
5) the temperature of dissolution medium

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63. Which behaviour of the drug has determining importance from the point of view of
absorption?

1) dissolution
2) crystal habit
3) crystal water content of the polimorf
4) secondary chemical structure
5) pKa value

64. Which factors has importance in facilitated diffusion?

1) carrier molecule
2) chemical energy
3) difference in hydraulic pressure on both side of the membrane
4) concentration gradient
5) competitive inhibition

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3 . A s s o c ia t io n s

Please, answer the following questions or combine the right letters with the right numbers.

65. How many per cent of the human bodys mass is the

1. extracellular fluid? A) 76
2. interstitial fluid? B) 58
3. plasma water? C) 41
4. total body water (TBW)? D) 17
5. intracellular fluid? E) 13
F) 4

66. Choose the correct unit for each term or sign.

1. ClT A) h-1
2. AUCT B) -
3. bioavailability C) L/h
4. absorbed fraction(f) D) h.mg/L
5. ka E) %
F) mg/L

67. Which is the most typical biotransformation reaction of each substance?

1. chloramphenicol A) acid-amid hydrolysis

2. cocaine B) glucuronic acid conjugation
3. sulfonamides C) nitro group reduction
4. steroids D) sulfate conjugation
5. lidocaine E) acetylation
F) ester hydrolysis

68. Join the pharmacons with the tissues, organs in which they can be accumulated.

1. thiopental A) liver, nail, skin

2. tetracyclines B) fat
3. iodides C) muscles
4. chloroquine D) growing bones, teeth
5. griseofulvin E) thyroid gland
F) liver, pancreas, leukocytes

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69. Which pharmacon and what kind of harm does it do?

1. petidine
2. caffeine
3. hepatotoxic substances
4. salicylates
5. antimetabolites

A) serious developmental diseases, abortion

B) increasing haemo- philiac liability
C) cause(s) no harm
D) increasing number of icterus
E) depression of the CNS and hypoxia
F) damage in liver, icterus

70. Combine the following symbols and their meaning!

A. cumulating factor
B. loss factor
C. persistency factor
D. average steady-state concentration
E. fluctuation

71. Combine the transport processes and the drugs (one transport process may be combined
with several drugs)!

1. convective transport A. Vitamine B12

2. active transport B. kvarter ammonium
compounds
3. facilitated diffusion C. heart-glycosides
4. ion-pair formation D. ionised sulphonamides
5. pynocitosis E. Vitamine A
F. Na+
G. alcohol

72. Which equation describes which transport process?

1. passive diffusion
2. convective transport
3. active transport
4. facilitated diffusion

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73. Which factors are needed for which transport process? (one transport process may be
combined with more factor)

1. passive transport
2. facilitated diffusion
3. convective transport
4. active transport
5. ion-pair formation
6.pynocitosis

A. it goes according the concentration gradient

B. carrier molecule
C. it goes opposite to concentration gradient
D. chemical energy (ATP)
E. transcellular transport
F. paracellular transport
G. production of vacuole
H. concentration differences on both sides of the memebrane
I. hydrostatic pressure difference

74. Sign molecules with A, which produce autoinduction, with B produce foreign induction!

1. probenicide
2. phenobarbitone
3. alcohol
4. griseofulvine
5. phenylbutazone
6. phenytoin
7. meprobamate

75. Combine numbers with capitals, where enzyminductor produces foreign induction!

1. antihistamine A. phenobarbitone
2. meprobamate B. chlortetracycline
3. phenobarbitone C. bilirubin
4. phenylbutazone D. cortisole
5. phenytoine E. aminopyrine
F. chloramphenicole
G. varfarine

76. Which type of metabolism functionate in which age in children?

1. cysteine conjugation A. just when born

2. glycine conjugation B. from first week
3. sulfation C. 1 month age
4. reduction, oxidization D. 2 months age
5. acetylation E. 3 months age
6. glucuronide conjugation
7. glutamine conjugation

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77. Which enzymes may be found in which juices? (One juice may consist of more
enzymes)

1. mouth A pepsine
2. oesophagus B. trypsine
3. stomach C. amylase
4. duodenum D. ptyaline
5. jejunum E. lipase
6. ileum F. chymotrypsine
7. rectum G. enterocynase
H. lactose

78. Combine the numbers and capitals, if K = kl+k3!

A. k1
B. k2
C. k3
D. ka

79. Which compounds eliminated more rapid, if the pH of urine is basic (A) or acidic (B)?

1. acetazolamide
2. amphetamine
3. codeine
4. nalidixic acid
5. morphine
6. chinin
7. nitrofurantoine

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80. Combine the blood level equations with the scheme of blood level curves!

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81. Combine the compartment scheme with blood level curve!

82. Combine the elimination way with compounds! (One elimination rout may suits for
more compounds)

1. kidney A. camphor
2. bile B. ammoniumchloride
3. intestine C. salicylic acid
4. saliva D. strychnine
5. sweet E. Vitamine B1
6. lung F. erythromycine
7. milk G. doxycycline
H. digoxin

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83. Combine the numbers with capitals to give the name of transport processes!

A. passive diffusion
B. convective transport
C. phagocytosis
D. facilitated diffusion
E. ion-pair mechanism
F. active transport

84. What characterise the structure specific molecules (A) and non specific molecules (B)
from the point of view of drug-receptor interaction?

1. pharmacological action is independent of thermodynamic activity (low doses are

needed)
2. pharmacological action is highly depend on the thermodynamic activity (high doses
are needed)
3. interaction with receptors depends on chemical reactivity, the presence of
characteristic functional groups, the same surface has the receptor and the molecule
4. effect highly depends on chemical structure
5. pharmacological effect is the same, inspire the chemical structure is different
6. small changes in chemical structure results in dramatical changes in
pharmacological effect
7. small changes in chemical structure does not alter the effect

85. Combine the numbers with capitals to sign the nature of interaction!

A. food
B. receptor
C. proteine
D. enzymes
E. glucuronides

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86. Combine the numbers with capitals!

A. chemical antagonism
B. competitive antagonism
C. partial antagonism
D. no competitive antagonism
E. antagonism does not produce steady state

l. Drug is substituted on the receptor by another drug. The process is reversible,

amount of the drug in biophase depends on the actual concentration of antagonist.
2. Antagonist molecule has great affinity, but intrinsic activity is law.
3. The agonist and antagonist molecules bind to different receptors and produce
opposit pharmacological effect.
4. Interaction of two different molecules out of receptor results in inactive complex.

87. Combine the numbers with capitals!

A. chemical equivalence
B. therapeutic equivalence
C. biopharmaceutical equivalence
D. pharmaceutical equivalence
E. clinical equivalence

1. Dosage form containing the same dose of same active ingredient with the same
chemical structure. The quality and quantity of auxiliary materials are different.
2. The same dosage form containing the same dose of same active ingredient with the
same chemical structure.
3. Dosage form containing the same dose of same active ingredient with the same
chemical structure, which has the same bioavailability.
4. Dosage form containing the same dose of same active ingredient with the same
chemical structure, which has the same therapeutic effect.

88. How does the bioavailabilty change during the processes signed with numbers?

A. enhance
B. reduced
C. does not change

1. In the case of rapid gastric emptying.

2. Size reduction of particles, when it absorbes from the stomach.
3. Producing a highly water soluble complex from the active ingredient.
4. When the absorption rate constant is lower, than the disintegration and dissolution
of solid dosage form.
5. When the metabolism of the drug enhances, but the metabolite is not active.

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89. Combine the conjugation processes with the molecules, enzymes, to-factors. (One
mechanism may be combined with more factors)

1. glucuronide conjugation A. S-adenosylmethionin

2. sulphate conjugation B. acetylating enzym
3. glutamine conjugation C. Mg, Mn, Co
4. acetylation D. PAPS
5. methylation E. UDPGA
6. glycine conjugation F. coensym A
G. acetyltransferase

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 BIOPHARMACY

4 . R e la t io n A n a ly s is

The sentences below contain a declaration and reasoning. Please, use the letter of one of
these statements by each sentence:

A): declaration and reasoning are both true and there is a connection between them
B): declaration and reasoning are both true and there is no connection between them
C): declaration is true, reasoning is false
D): declaration is false, reasoning is true
E): declaration and reasoning are both false

90. Steroid hormones are partially excreted by bile but reabsorbed since their ionic form
gets into gut.

91. Insulin is not given per os since it is not absorbed from the large intestine.

92. Acidosis increases alkalosis decreases phenobarbital caused sleeping time because the
distribution of drug is affected by pH.

93. Chloroquine is an effective antimalarial medicine since its concentration in tissues is

hundred times as much as its plasma concentration.

94. Digoxins apparent volume of distribution is many times as much as body mass
because a large quantity of the pharmacon accumulates in tissues.

95. Oral antidiabetics are hardly bound to plasma proteins so phenylbutazone increases the
intensity of their effect.

96. Chlorpromazine stimulates the hypnotic effect of barbiturates since it blocks the
microsomal oxydase enzymes in liver.

97. Methylxanthines are not excreted into the breast milk because they are water-soluble.

98. Anticoagulant effect of acenokumarol develops quickly because its absorption is good
from the GI tract.

99. Disulfiram is an effective drug for alcohol detoxication since it stimulates the
metabolism of alcohol in liver.

100. Theophyllines kinetics of metabolism is first order within the therapeutic interval in
blood. At higher concentrations however, it becomes zero-order because the enzymes
that participate in its metabolism are saturated.

101. Oral antidiabetics are usually bound well to plasma proteins so they are suitable to treat
for type II of diabetes mellitus.

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 BIOPHARMACY

102. Ammonium chloride is given in case of acute amphetamine intoxication because it

acidifies urine and increases urinary elimination of amphetamine significantly.

103. Methylxanthines are eliminated unchanged with urine so their half-life is very short (1-2
hours).

104. There is no big difference in the apparent volume of distribution (950 liters), clearance
(300 ml/min) and elimination half life of digoxin between a fat (90-110 kgs) and an
average (~70 kgs) adult. Since the body mass of obese people are greater, it should be
taken into consideration when calculating saturating and maintenance dose.

105. 60-80 per cent of kinidine is metabolised in liver because it binds very well to a-1-
glycoproteins.

106. Fat-soluble medicines are hardly absorbed from the surface of skin so systemic effect
can not be produced by drugs that are applied on the skin.

107. Warfarin cure should be started with 10-15 milligrams and after saturation (2-4 days) the
maintenance dose should be set based on prothrombin time since the half-life of warfarin
is long.

108. Salts of weak bases are totally dissociated in the gastric juice so they are not reabsorbed
from stomach but they are from the slightly alkaline environment of gut.

109. The change of gastric motility does not influence the Cmax value of the orally given
pharmacon that is absorbed from the small intestine because increase or decrease of
motility changes the pharmacons velocity of getting into gut.

110. Those molecules pass through the membranes with convective transport which are water
soluble and their molecular weight is between 150-400, while the diameter of pores is
between 7-10 A and the viscosity of the liquid determines the rate of transport.

111. Circadian rhythm is controlled by the external biological clock, while the changes of
enzyme activity by day and night synchronises the activity of the organism.

112. Rate of drug absorption during oral administration highly depends on the disintegration
time of solid dosage form and the dissolution rate of drug, while in consecutive
processes the rate limiting step is always the slowest one.

113. Drug interactions decrease absorption, while complexes are formed with reduced water
solubility.

114. Application of targeted delivery systems reduce the unwanted side effects, while smaller
amount of drug enters to the organism and it liberates only at the site of action.

115. Methylation is the most important conjugation mechanism, while it requires

methyltransferase enzyme and different to-factors are needed (Mg, Mn, Co etc.).

116. Acetylation does not functionate in new-horns, while the slow and rapid acetylation
ability develops only after 1 year old age.

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BIOPHARMACY

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 BIOPHARMACY

117. The dissolution and absorption rate of drugs may significantly elevated by chelate
formation and with the production of solid-solid solutions, while the drug is in a
molecularly dispersed form.

118. The amorph form of penicillin G absorbs better than the crystal form, while the
dissolution of crystal molecules requires higher energy.

119. Drug preparations containing sensitive compound for gastric juice and the enterosolvent
coated preparations have to be administered with 250 ml water, while the ice water
results quick emptying of stomach, therefore the drug spends shorter time there.

120. Presence of food in stomach delay the absorption of alcohol, while alcohol induce
increased acid secretion.

121. Optimised, controlled release dosage form is able to produce constant blood level during
the required time interval, while the liberation and elimination rates are equal.

122. Retard preparations with zero order liberation kinetic of initial and maintenance doses
provide constant blood level, if the maintenance dose starts to liberate, when the initial
dose reaches its maximum.

123. In the oesophagus the absorption of drugs is limited by the transit time, while the
preparations must be taken with high amount of water, to prevent the instant liberation
of drug.

124. Value of absorption not always corresponds with the dissociation constant as it is
required, while the anatomy of GI tract, the peristalsis, its physiologically present
content serves first of all the ingestion of food and enhance the absorption of food.

125. No absorption takes place in the colon, while there is no peristalsis, and practically there
are no enzymatic processes.

126. In pulmonary absorption an important factor is the state of mucosa, while the inhalasols
provide first of all local effect.

127. The protein binding of morphine is elevated in elderly, while aging generally produced
hypoalbuminaemia.

128. The initial dose is twice as the maintenance dose, while the enhanced first dose produce
immediate effect.

129. On the base of urinary data one can calculate pharmacokinetic parameters, while the
expressed amount of drug excretes via the kidney.

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 BIOPHARMACY

5 . C a lc u la t io n s

Please, choose the right result below each exercise or question.

130. Calculate the elimination half life of penicillin if its elimination coefficient is 0.89 h-1.

A. 0.62 h
B. 0.78 h
C. 2.12 h
D. 1.12 h
E. 0.89 h

131. Determine the elimination constant of theophylline if the total body clearance is
2.96 L/h and its distribution volume is 37456 mL.

A. 7.903 h-1
B. 0.790 h-1
C. 0.079 h-1
D. 0.008 h-1
E. 1.098 h-1

132. Choose the AUCT value of lidocaine if the intaken dose is 0.2 g and the total body
clearance is 44.54 L/h.

A. 4.490 h.mg/L
B. 0.004 h.mg/L
C. 8.908 h.mg/L
D. 8908 h.mg/L
E. 44.9 h.mg/L

133. Calculate how many milligrams of lidocaine should be given in infusion hourly if the
plateau must be 4mg/L. The total body clearance of lidocaine is 44540 mL/h.

A. 1782 mg/h
B. 11.14 mg/h
C. 111.4 mg/h
D. 178.2 mg/h
E. 17.8 mg/h

134. Determine the physiological availability of per os given 20 milligrams of oxoprenolol

if AUCT is 503.6 h.g/L. Its intravenous value is 618.6 h.g/L.

A. 81.41 %
B. 0.81 %
C. 31.15 %
D. 68.85 %
E. 100.0 %

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 BIOPHARMACY

135. Calculate the bioavailability of theophylline tablet. 250 milligrams of theophylline

injections AUCT is 84.46 h.mg/L. 300 milligrams of theophylline tablets AUCT is
101.35 h.mg/L.

A. 83.83%
B. 100.0%
C. 10.0%
D. 90.0%
E. 66.6%

136. Calculate the relative bioavailability of chloroquine suppository. AUCT of a 350 mg

tablet is 23.88 h.mg/L and the AUCT of the suppository that has 1050 milligrams of
active compound is 34.08 h.mg/L.

A. 33.33%
B. 70.07%
C. 21.02%
D. 47.57%
E. 52.43%

137. Determine the renal clearance of gentamicin if the amount of hourly-secreted

pharmacon is 12.94 milligrams in urinE) The average plasma concentration in the
observed period is 3070 g/L.

A. 23.7 L/h
B. 0.24 L/h
C. 4.21 L/h
D. 39.27 L/h
E. 44.21 L/h

138. Calculate the total body clearance of 0.5 grams of paracetamols per os dosage if its
AUCT value is 21.59 h.mg/L and the patients factor of liver function is 0.7.

A. 16.21 L/h
B. 23.15 L/h
C. 262.72 L/h
D. 33.16 L/h
E. 23.70 L/h

139. Determine the maintenance dose of paracetamol that provides 9 mg/L balanced plasma
concentration in case of a per os intake repeated in every 6 hours. The total body
clearance of the patient (suffering from liver disease) is 6.945 L/h.

A. 1250 mg
B. 540 mg
C. 54 mg
D. 375 mg
E. 7.77 mg

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 BIOPHARMACY

140. Calculate the excretion rate of meperidine in the kidneys if half-life of the active
compound is 3.2 h in the plasma and 20 per cent is eliminated unmodified with urine.

A. 0.032 h-1
B. 0.043 h-1
C. 0.054 h-1
D. 0.065 h-1
E. 0.076 h-1

141. Determine the total body clearance of theophylline where the pharmacon has a 9.6 hour
long elimination half time and its distribution volume is 23.85 L.

A. 1.13 L/h
B. 1.22 L/h
C. 1.49 L/h
D. 1.60 L/h
E. 1.72 L/h

142. Determine the total body clearance of metoprolol if the pharmacons t1/2 value is 3.2 h
and its distribution volume is 4.2 L/kg. The patient is 50 kilograms heavy.

A. 65.6 h-1
B. 45.5 L/h
C. 3.0 L/kg/h
D. 45.5 L/kg/h
E. 65.6 L/h

143. A 70-kg heavy person had a phenobarbital overdose. At the first time his blood level
had been 90 g/ml and 5 hours later, it decreased to 63 g/ml. Calculate the zero order
elimination rate if the distribution volume of drug is 1 L/kg.

A. 70 mg/h
B. 378 g/h
C. 378 mg/h
D. 378 mg/L/h
E. 5.4 g/h

144. Calculate the total body clearance of a pharmacon that was measured in a 52.7-kg
heavy patient. The elimination half life based on the plasma concentration change was
0.5744 h. Its distribution volume was 1 L/kg.

A. 63.6 L/kg/h
B. 1.27 L/kg/h
C. 0.287 L/kg/h
D. 14.36 L/h
E. 41.4 L/kg/h

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 BIOPHARMACY

145. Fate of drug in organism when l00 mg dose is administered may be characterised by
open one compartment model. Volume of distribution is 17 litre, biological half life is
1.5 hours. What is the value of AUC0?

a. 1.278 g/mlhour
b. 4.835 g/mlhour
c. 12.78 g/mlhour

146. What is the clearance value of that drug, which is administered in 250 mg dose,
it distributes immediately in 14.71 litre volume and its elimination rate constant is
0.48 hour-1?

a. 1190 ml/hour
b. 119 ml/hour
c. 101.9 ml/hour

147. What is the value of biological half life, if cop =88.87 mg/ml and the value of
plasmaconcentration at time t=6 hours is 36.81 mg/ml?

a. 4.7 hours
b. 5.3 hours
c. 14.7 hours

148. Fate of drug in organism may be characterised by open two compartment model and
B=529 mg/ml, =0.118, cop=2721mg/ml, biological half life is 10.5 hours. What is the
value of summarised elimination rate constant (k13)?

a. 1.023 hours-1
b. 10.23 hours-1
c. 0.1023 hours-1

149. Which is the value of time to reach maximal plasma level (tmax) in a patient with
reduced liver function, when the value of biological half life (t1/2) is doubled as the
normal (1.5 hours) and the absorption rate constant (ka) is unchanged (2.1 hour-1)?

a. t max (normal) = 9.2 hours t max (reduced) = 11.8 hours

b. t max (normal) = 0.92 hours t max (reduced) = 1.18 hours
c. t max (normal) = 9.02 hours t max (reduced) = 10.18 hours

150. A patient with renal failure is treated by normal dose (D=200 mg).
The volume of distribution (Vd ) in a normal patient is 1.7 litre, in patient with renal
failure is 0.93 litre. The elimination rate constant (kel) of normal patient is 0.086 hour-1.
What is the value of kel in patient with reduced function, when its AUC value is five
fold that of normal patient?

a. 0.215 hour-1
b. 0.031 hour-1
c. 0.31 hour-1

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 BIOPHARMACY

151. What is the value of biological half life (t1/2), when A = 26.8 g/ml, B = 31.5 g/ml,
maximal plasma concentration (cmax) is 12 g/ml, time to reach maximal plasma
concentration (tmax) is 2.1 hours? The fate of drug may be characterised by open one
compartment model.

a. 1.51 hours
b. 2.51 hours
c. 3.51 hours

152. What is the optimal liberation rate constant in the case of a preparation with zero order
dissolution process, when the optimal blood level is 400 mg and the biological half life
is 6 hours?

a. 0.464 mg/hour
b. 0.146 mg/min
c. 46.4 mg/hour

153. Tablet is produced from spairingly soluble material using polyvinil alcohol. The blood
level values after administration are as follows:

Time (hour)
Form 1 2 3 5 7 10
Plasma levels (g/ml)
L 0.25 0.37 0.52 0.83 0.52 0.45

Calculate the value of area under blood level us time curve (AUC0t)using the trapezoid rule,
and calculate the value of (AUC0), when cop = 1.77 mg/ml and t1/2 = 3 hours.

a. (AUC010)= 50.35 g/mlhour (AUC10) =26.30 g/mlhour

b. (AUC010)= 5.035 g/mlhour (AUC10) =2.630 g/mlhour
c. (AUC010)= 0.5035 g/mlhour (AUC10) =0.263 g/mlhour

154. The patient is treated in every 8 hour with 80 mg dose. T volume of distribution is 1.997
litre, biological half life is 2.8 hours. Which doses are needed to reach the same average
plasma level, when the same dose is given in every 12 hours (F=0.98)?

a. 100 mg
b. 120 mg
c. 115 mg

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 BIOPHARMACY

6 . A n s we r k e y
1. C 56. C 74. 3.B 84. 3.A
2. C 57. E 74. 4.B 84. 4.A
3. D 58. E 74. 5.A 84. 5.B
4. A 59. D 74. 6.B 84. 6.A
5. E 60. A 74. 7.A 84. 7.B
6. B 61. C 75. 1.A 85. 1.A
7. B 62. D 75. 2.G 85. 2.C
8. E 63. C 75. 3.C, F 85. 3.D
9. A 64. D 75. 4.E 85. 4.E
10. C 65. 1.D 75. 5.D 85. 5.B
11. D 65. 2.E 76. 1.E 86. 1.B
12. C 65. 3.F 76. 2.E 86. 2.C
13. E 65. 4.B 76. 3.A 86. 3.D
14. B 65. 5.C 76. 4.B 86. 4.A
15. A 66. 1.C 76. 5.C 87. 1.D
16. A 66. 2.D 76. 6.D 87. 2.A
17. C 66. 3.E 76. 7.E 87. 3.C
18. D 66. 4.B 77. 1.D 87. 4.B
19. E 66. 5.A 77. 3.A, E 88. 1.B
20. C 67. 1.C 77. 4.B, C, F, E 88. 2.A
21. A 67. 2.F 77. 5.C 88. 3.A
22. B 67. 3.D 77. 6.E, G 88. 4.C
23. C 67. 4.B 78. 1.D 88. 5.B
24. A 67. 5.A 78. 2.A 89. 1.E
25. B 68. 1.B 78. 3.B 89. 2.D
26. D 68. 2.D 78. 4.C 89. 3.B
27. C 68. 3.E 79. 1.A 89. 4.G
28. B 68. 4.F 79. 2.B 89. 5.A, C
29. E 68. 5.A 79. 3.B 89. 6.F
30. D 69. 1.E 79. 4.A 90. C
31. E 69. 2.D 79. 5.B 91. C
32. D 69. 3.F 79. 6.B 92. A
33. A 69. 4.B 79. 7.A 93. B
34. D 69. 5.A 80. 1.B 94. A
35. C 70. 1.C 80. 2.A 95. D
36. C 70. 2.B 80. 3.C 96. C
37. B 70. 3.A 80. 4.D 97. E
38. A 70. 4.E 81. 1.B 98. D
39. E 71. 1.D 81. 2.C 99. C
40. B 71. 2.C, F 81. 3.D 100. A
41. D 71. 3.A 81. 4.A 101. B
42. A 71. 4.B 82. 1.C 102. A
43. C 71. 5.E 82. 2.D 103. E
44. E 72. 1.B 82. 3.G 104. C
45. D 72. 2.A 82. 4.H 105. B
46. B 72. 3.D 82. 5.E 106. E
47. E 72. 4.D 82. 6.A, B 107. A
48. B 73. 1.A, E, H 82. 7.F 108. A
49. A 73. 2.A, B, E, H 83. 1.A 109. D
50. A 73. 3.A, F, I 83. 2.D 110. B
51. B 73. 4.B, C, E, D 83. 3.B 111. C
52. E 73. 5.A, E, F 83. 5.C 112. A
53. C 73. 6.E, G 83. 6.F 113. E
54. D 74. 1.A 84. 1.A 114. A
55. B 74. 2.A 84. 2.B 115. D

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 BIOPHARMACY
116. C 126. B 136. D 146. B
117. A 127. D 137. C 147. A
118. D 128. D 138. A 148. C
119. A 129. B 139. D 149. B
120. B 130. B 140. B 150. B
121. C 131. C 141. E 151. A
122. A 132. A 142. B 152. C
123. E 133. D 143. C 153. B
124. B 134. A 144. A 154. B
125. E 135. B 145. C

35