| Refining the benefit-risk framework for the assessment of medicines: valuing and weighting benefit and risk parameters. | |
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MedLine Citation:
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PMID: 21252937 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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A common framework is necessary for the transparent articulation of the benefits and risks of a therapeutic product across disparate stakeholders. The assignment of value and weighting to each component parameter presents challenges deriving from different stakeholder objectives, methods, and perspectives. Building on prior experiences with a validated framework approach, this forum focused on identifying challenges and approaches to the assignment of values and weightings using a case study applied to a hypothetical medicinal product. |
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Authors:
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S Walker; L Liberti; N McAuslane; B S Levitan |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Clinical pharmacology and therapeutics Volume: 89 ISSN: 1532-6535 ISO Abbreviation: Clin. Pharmacol. Ther. Publication Date: 2011 Feb |
Date Detail:
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Created Date: 2011-01-21 Completed Date: 2011-02-28 Revised Date: 2012-01-26 |
Medline Journal Info:
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Nlm Unique ID: 0372741 Medline TA: Clin Pharmacol Ther Country: United States |
Other Details:
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Languages: eng Pagination: 179-82 Citation Subset: AIM; IM |
Affiliation:
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CMR International Institute for Regulatory Science, London, UK. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Drug Therapy* Drug and Narcotic Control Humans Risk Assessment* |
| Comments/Corrections | |
Erratum In:
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Clin Pharmacol Ther. 2011 Jun;89(6):928 Clin Pharmacol Ther. 2012 Jan;91(1):150 Note: Levitan, B S [added] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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