A Universal Framework for the Benefit-Risk Assessment of Medicines: Is This the Way Forward?

Author:

Walker Stuart,McAuslane Neil,Liberti Lawrence,Leong James,Salek Sam

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Reference23 articles.

1. Center for Innovation in Regulatory Science. Measuring benefit and balancing risk: strategies for the benefit-risk assessment of new medicines in a risk-averse environment. http://www.cirsci.org/sites/default/files/June_2008.pdf. Published 2008. Accessed November 20, 2013.

2. Leong J, McAuslane N, Walker S, Salek S. Is there a need for a universal benefit-risk assessment framework for medicines? Regulatory and industry perspectives. Pharmacoepidemiol Drug Saf. 2013;22:1004–1012.

3. European Medicines Agency. Reflection paper on benefit-risk assessment methods in the context of the evaluation of marketing authorization applications of medicinal products for human use. http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/01/WC500069634.pdf. Published 2008. Accessed November 20, 2013.

4. European Medicines Agency. Benefit-risk methodology project: development and testing of tools and processes for balancing multiple benefits and risks as an aid to informed regulatory decisions about medicinal products. http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/07/WC500109477.pdf. Published 2009. Accessed November 20, 2013.

5. European Medicines Agency. Benefit-risk methodology project: work package 2 report. Applicability of current tools and processes for regulatory benefit-risk assessment. http://www.ema.europa.eu/docs/en_GB/document_library/Report/2010/10/WC500097750.pdf. Published 2010. Accessed November 20, 2013.

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