Structured benefit–risk evaluation for medicinal products: review of quantitative benefit–risk assessment findings in the literature

A favorable benefit–risk profile remains an essential requirement for marketing authorization of medicinal drugs and devices. Furthermore, prior subjective, implicit and inconsistent ad hoc benefit–risk assessment methods have rightly evolved towards more systematic, explicit or “structured” approac...

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Bibliographic Details
Published in:Ther Adv Drug Saf
Main Authors: Kürzinger, Marie-Laure, Douarin, Ludivine, Uzun, Ievgeniia, El-Haddad, Chantal, Hurst, William, Juhaeri, Juhaeri, Tcherny-Lessenot, Stéphanie
Format: Artigo
Language:Inglês
Published: SAGE Publications 2020
Subjects:
Review
Online Access:https://ncbi.nlm.nih.gov/pmc/articles/PMC7727082/
https://ncbi.nlm.nih.gov/pubmed/33343857
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/2042098620976951
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