PHARMACOVIGILENCE AND CLINICAL TRIALS

Himanshu Gupta's picture
TitlePHARMACOVIGILENCE AND CLINICAL TRIALS
Publication TypeJournal Article
Year of Publication2009
AuthorsSharma, A, Gupta H
Journal TitleThe Pharma Review
Volume7
Issue39
Journal Date05/2009
Keywordsclinical trial pharmacovigilence
Abstract

Clinical and preclinical studies cannot guarantee absolute safety of a drug. Therefore pharmacovigilance has been introduced to identify and respond to drug safety issue. It is related to the surveillance of drugs once they are released for use in the community (post marketing surveillance) and relies on voluntary reporting, prescription monitoring, medical records and statistical studies in the population. It is important that adequate Pharmacovigilance standards are introduced to monitor adverse reactions of products, before its launches in country like India. In this article we have tried to give an insight view on different aspect of pharmacovigilance.