Pharmacovigilance for clinical trials in India: Current practice and areas for reform

Pharmacovigilance for clinical trials in India: Current practice and areas for reform

Keeping in mind India′s increasing participation in multinational trials, this article explores potential areas of Indian pharmacovigilance, requiring reform and provides recommendations for building a robust safety reporting system. Internal discrepancies exist between Schedule Y and Central Drugs...

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Bibliographic Details
Main Authors: Ballari Brahmachari, Melanie Fernandes, Arun Bhatt
Format: Article
Language:English
Published: Wolters Kluwer Medknow Publications 2011-01-01
Series:Perspectives in Clinical Research
Subjects:
Development safety update report
expedited reporting
pharmacovigilance
serious adverse event
suspected unexpected serious adverse reaction
Online Access:http://www.picronline.org/article.asp?issn=2229-3485;year=2011;volume=2;issue=2;spage=49;epage=53;aulast=Brahmachari

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http://www.picronline.org/article.asp?issn=2229-3485;year=2011;volume=2;issue=2;spage=49;epage=53;aulast=Brahmachari

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