CMR International Institute for Regulatory Science Workshop on Measuring Benefit and Balancing Risk 19-20 June 2008, Washington, DC. Measuring benefit and balancing risk: Strategies for the benefit-risk assessment of new medicines in a risk-averse environment

Clinical Pharmacology and Therapeutics

Volumn 85, Issue 3, 2009, Pages 241-246

  Walker, S ^a   McAuslane, N ^a   Liberti, L ^a   Salek, S ^b  

^a CMR International Institute for Regulatory Science   (United Kingdom)

^b CARDIFF UNIVERSITY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CONFERENCE PAPER; DRUG EFFICACY; DRUG INDUSTRY; DRUG MARKETING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; HUMAN; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PUBLIC HEALTH; RISK BENEFIT ANALYSIS; ANIMAL; DRUG SCREENING; EDUCATION; INTERNATIONAL COOPERATION; LEGAL ASPECT; METHODOLOGY; PHARMACEUTICS; RISK ASSESSMENT; STANDARD; UNITED STATES;

NEW DRUG;

ANIMALS; DISTRICT OF COLUMBIA; DRUG EVALUATION, PRECLINICAL; DRUGS, INVESTIGATIONAL; EDUCATION; HUMANS; INTERNATIONALITY; RISK ASSESSMENT; TECHNOLOGY, PHARMACEUTICAL;

EID: 60349128681     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2008.277     Document Type: Conference Paper

References (5)

1. US Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Premarketing Risk Assessment 〈http://www.fda.gov/ CDER/guidance/6357fnl.htm〉 (March 2005).
2. Identification of drug and biological products deemed to have risk evaluation and mitigation strategies for purposes of the Food and Drug Administration Amendments Act of 2007. Federal Register 73, 16313-16314 (27 March 2008).
3. European Medicines Agency (EMEA). Report of the CHMP Working Group on Benefit-Risk Assessment Models and Methods. EMEA 〈http://www.emea. europa.eu/pdfs/human/brmethods/1540407en.pdf〉 (19 January 2007).
4. Mussen, F., Salek, S. & Walker, S. A quantitative approach to benefit-risk assessment of medicines - part 1: the development of a new model using multi-criteria decision analysis. Pharmacoepidemiol. Drug Saf. 16 (suppl. 1), S2-S15 (2007).
5. European Medicines Agency (EMEA). Reflection Paper on Benefit-Risk Assessment Methods in the Context of the Evaluation of Marketing Authorisation Applications of Medicinal Products for Human Use. EMEA 〈http://www.emea.europa.eu/pdfs/human/brmethods/1540407enfin.pdf〉 (19 March 2008).