Structured frameworks to increase the transparency of the assessment of benefits and risks of medicines: current status and possible future directions
File(s)
Accepted version
Author(s)
Type
Journal Article
Abstract
Structured frameworks for benefit-risk analysis in drug licensing decisions are being implemented across a number of regulatory agencies worldwide. The aim of these frameworks is to aid the analysis and communication of the benefit-risk assessment throughout the development, evaluation, and supervision of medicines. In this review, authors from regulatory agencies, pharmaceutical companies, and academia share their views on the different frameworks and discuss future directions.
Date Issued
2015-09-11
Date Acceptance
2015-08-01
Citation
Clinical Pharmacology & Therapeutics, 2015, 98 (5), pp.522-533
ISSN
1532-6535
Publisher
American Society for Clinical Pharmacology and Therapeutics
Start Page
522
End Page
533
Journal / Book Title
Clinical Pharmacology & Therapeutics
Volume
98
Issue
5
Copyright Statement
This is the peer reviewed version of the following article: Pignatti, F., Ashby, D., Brass, E., Eichler, H.-G., Frey, P., Hillege, H., Hori, A., Levitan, B., Liberti, L., Löfstedt, R., McAuslane, N., Micaleff, A., Noel, R., Postmus, D., Renn, O., Sabourin, B., Salmonson, T. and Walker, S. (2015), Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines: Current Status and Possible Future Directions. Clinical Pharmacology & Therapeutics, 98: 522–533, which has been published in final form at https://dx.doi.org/10.1002/cpt.203. This article may be used for non-commercial purposes in accordance With Wiley Terms and Conditions for self-archiving.
Sponsor
Commission of the European Communities
Identifier
http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000363405000022&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
Grant Number
115004
Subjects
Science & Technology
Life Sciences & Biomedicine
Pharmacology & Pharmacy
NONPRESCRIPTION DRUGS
DECISION-MAKING
Communication
Drug-Related Side Effects and Adverse Reactions
Europe
Forecasting
Government Agencies
Humans
Risk Assessment
United States
United States Food and Drug Administration
1115 Pharmacology And Pharmaceutical Sciences
Publication Status
Published