Implementing Benefit-Risk Assessment for the Periodic Benefit-Risk Evaluation Report

Conclusions: A structured, systematic approach to defining a medicine’s B-R profile will help ensure compliance with this ICH objective for the PBRER.

http://dij.sagepub.com/cgi/content/abstract/50/3/342?rss=1

Source: Therapeutic Innovation and Regulatory Science - April 20, 2016 Category: Drugs & Pharmacology Authors: Warner, M. R., Wolka, A. M., Noel, R. A. Tags: Product Safety Source Type: research

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