Is there a need for a universal benefit-risk assessment framework for medicines? Regulatory and industry perspectives
Author:
Affiliation:
1. School of Pharmacy and Pharmaceutical Sciences; Cardiff University; Cardiff UK
2. Centre for Innovation in Regulatory Science; London UK
Publisher
Wiley
Subject
Pharmacology (medical),Epidemiology
Link
http://onlinelibrary.wiley.com/wol1/doi/10.1002/pds.3464/fullpdf
Reference13 articles.
1. Food and Drug Administration (FDA) Communicating Risks and Benefits: An Evidence-based User's Guide http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM268069.pdf
2. European Medicines Agency (EMA) Benefit-Risk Methodology Project http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/07/WC500109477.pdf
3. Benefit-risk assessment: to quantify or not to quantify, that is the question;Yuan;Pharmacoepidemiol Drug Saf,2011
4. Application of the BRAT framework to case studies: observations and insights;Levitan;Clin Pharmacol Ther,2011
5. A Review of Quantitative Risk-Benefit Methodologies for Assessing Drug Safety and Efficacy - Report of the ISPOR Risk-Benefit Management Working Group;Guo;Value Health,2010
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