Is quantitative benefit–risk modelling of drugs desirable or possible?

Preliminary research results with drug regulators in several European Agencies show that quantitative models developed with groups of assessors and specialists can integrate scientific data with expert value judgements, thereby extending the capabilities of regulators, and stimulating new insights a...

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Bibliographic Details
Published in:Drug discovery today. Technologies 2011, Vol.8 (1), p.e3-e10
Main Authors: Phillips, Lawrence D., Fasolo, Barbara, Zafiropoulos, Nikolaos, Beyer, Andrea
Format: Article
Language:English
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Summary:Preliminary research results with drug regulators in several European Agencies show that quantitative models developed with groups of assessors and specialists can integrate scientific data with expert value judgements, thereby extending the capabilities of regulators, and stimulating new insights about key trade-offs. As a result, the rationale for the benefit–risk balance becomes more transparent, communicable and consistent.
ISSN:1740-6749
1740-6749
DOI:10.1016/j.ddtec.2011.03.001