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Pharmacovigilance Basics

Pharmacovigilance Basics

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Published by melvingeorge2003

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Published by: melvingeorge2003 on Jul 30, 2009
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Data Assessment in Pharmacovigilance
R.H.B. Meyboom
Definition of pharmacovigilance(WHO, 2002)
The science and activities relating to thedetection, assessment, understandingand prevention of adverse effects or anyother drug-related problem
Pharmacovigilanceis the same as ‘drugmonitoring’
Why pharmacovigilance?
Limited value of animal experimentsin predicting human safety
Clinical trials are limited in time andnumber of patients; are ‘artificial’.Patients are selected (adults, noother drugs, no other diseases). Notrepresentative of real-life use.
Rare or delayed serious reactions arelikely to remain unnoticed

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