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

By Lawrence D. Phillips, Barbara Fasolo, Nikolaos Zafiropoulos and Andrea Beyer


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

Topics: RS Pharmacy and materia medica
Publisher: Elsevier
Year: 2011
DOI identifier: 10.1016/j.ddtec.2011.03.001
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Provided by: LSE Research Online
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