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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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Detalhes bibliográficos
Publicado no:Ther Adv Drug Saf
Main Authors: Kürzinger, Marie-Laure, Douarin, Ludivine, Uzun, Ievgeniia, El-Haddad, Chantal, Hurst, William, Juhaeri, Juhaeri, Tcherny-Lessenot, Stéphanie
Formato: Artigo
Idioma:Inglês
Publicado em: SAGE Publications 2020
Assuntos:
Acesso em linha: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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