Reporting of adverse events for marketed drugs: Need for strengthening safety database

Pharmacovigilance is an evolving discipline in the Indian context. However, there is limited regulatory guidance for adverse event reporting outside the purview of clinical trials. There are number of deficiencies in the framework for adverse event reporting from the perspective of pharma industry,...

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Bibliographic Details
Main Author: Aditi Anand Apte
Format: Article
Language:English
Published: Wolters Kluwer Medknow Publications 2016-01-01
Series:Perspectives in Clinical Research
Subjects:
Online Access:http://www.picronline.org/article.asp?issn=2229-3485;year=2016;volume=7;issue=3;spage=111;epage=114;aulast=Apte