Integrating risk minimization planning throughout the clinical development and commercialization lifecycle: an opinion on how drug development could be improved

Elaine H Morrato,1 Meredith Y Smith2 1Colorado School of Public Health, University of Colorado, Anschutz Medical Campus, Aurora, CO, 2EMD Serono, Inc, Rockland, MA, USA Abstract: Pharmaceutical risk minimization programs are now an established requirement in the regulatory landscape. However, phar...

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Bibliographic Details
Main Authors: Morrato EH, Smith MY
Format: Article
Language:English
Published: Dove Medical Press 2015-02-01
Series:Therapeutics and Clinical Risk Management
Online Access:http://www.dovepress.com/integrating-risk-minimization-planning-throughout-the-clinical-develop-peer-reviewed-article-TCRM