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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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Detalles Bibliográficos
Autor principal: Apte, Aditi Anand
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4936068/
https://www.ncbi.nlm.nih.gov/pubmed/27453826
http://dx.doi.org/10.4103/2229-3485.184781