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
Main Authors: Marie-Laure Kürzinger, Ludivine Douarin, Ievgeniia Uzun, Chantal El-Haddad, William Hurst, Juhaeri Juhaeri, Stéphanie Tcherny-Lessenot
Format: Article
Language:English
Published: SAGE Publishing 2020-12-01
Series:Therapeutic Advances in Drug Safety
Online Access:https://doi.org/10.1177/2042098620976951