Is there a need for a universal benefit-risk assessment framework for medicines? Regulatory and industry perspectives-Reference-Cited by-同舟云学术

Is there a need for a universal benefit-risk assessment framework for medicines? Regulatory and industry perspectives

Published:2013-06-05 Issue:9 Volume:22 Page:1004-1012
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Leong James¹,McAuslane Neil²,Walker Stuart¹²,Salek Sam¹

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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