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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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Bibliografiske detaljer
Udgivet i: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
Sprog:Inglês
Udgivet: SAGE Publications 2020
Fag:
Online adgang: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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