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Introduction to pharmacoepidemiology (8, historical background…
Introduction to pharmacoepidemiology
8, historical background
Thalidomide
Kefauver-harris Amendments
Drug withdrwal
1, background
7, pharmacoepidemiology vs epidemiology
2, introduction
Defination
Pharmacoepidemiology vs pharmacology
Adverse drug reaction
Type A
Type B
6, pharmacoepidemiology (ADR)
9, current drug approval process
Phase I
Phase II
Phase III
PhAse IV
Why phase IV important
Premarketing studies alsontend to be very artificial
Limited sample size
Premarketing clinicals trails homogenous subject
Safety and efficacy compare to placebo
Current initiatives
11, Patient safety movement
12, risk management
Pharmacovigilance activities