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Topics
Introduction: The Contribution of Epidemiology to the Study
of Drugs
The Drug Approval Process
Premarketing
k
Clinical
l
l Research
h
Post marketing Surveillance Methodologies (Randomized
Clinical trial, Observational epidemiologic surveys, CaseCase
control study, Cross-sectional study, Cohort study)
Meta analysis in Pharmacoepidemiology
Pharmacoeconomy Analysis
The Role of Epidemiology in Pharmaceutical Research,
Development and Marketing
Development,
What is
Pharmacoepidemiology?
What
h is the
h aim??
Safety
Adverse Drug Event
Economy
Evaluate the cost and effects of a pharmaceutical
product
Drugs Withdrawal
Gone, but not forgotten
Year
Name
Trade Name
Comment
1961
Thalidomide
Distavel
Valgis
Valgraine
Valgraine
1971
Diethylstilbe
strol
Stilboestrol
Year
Name
Trade
Name
Comment
2005
Co-proxamol
Distalgesic
C l i
Cosalgesic
2010
Sibutramine
Reductil
2011
Pioglitazone
Actos
2009 Efalizumab
Raptiva
Basic molecular and cell biology research have now come of age
Recombinant DNA
DNA, production of monoclonal antibody etc
Although different from traditional pharmacologic agents, products based on
biotechnology should be evaluated in the pharmaceutical context rather than the
production techniques that are employed.
Because of their unique production techniques used and their different mode of action,
it is likely that news pharmacoepidemiology methodologies will need to developed.
Duration
Rofecoxib
1999-2004
Fenfluramine
1979-1980
Temafloxacin
1992-1992
Troglitazon
1999-2000
1999
2000
Alosteron
2000-2000
Supofen
1985-1987
Ci
Cisapride
id
1993 2000
1993-2000
Grepafloxacin
1997-1999
Rapacuronium
1999-2001
Alat/tools
Uji Farmakoepidemiologi
Orientasi
Explanatory/knowledgeoriented question
Pragmatic/Decisionoriented question
Efikasi Obat
Subjek penelitian
Kemungkinan lain
Example
L
Long-term
t
effects
ff t
manifest after long periods of use
manifest
f after
f llong llatency periods
d
Adenocarcinoma
d
off the
h vagina d
due to
diethylstilbestrol
Low-frequency effects
can only be detected in large
populations
Eff ti
Effectiveness
i customary
in
t
practice
ti
patients
therapeutic situations
Area of Inquiry
Example
h lth
healthcare
settings
tti
emergency, ambulatory
b l t
care
healthcare professionals
Effi
Efficacy
i new indications
in
i di i
discovered after marketing
Modifiers of efficacy
concurrent drugs
disease severity
lifestyle