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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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Detalles Bibliográficos
Publicado en:Ther Adv Drug Saf
Autores principales: Kürzinger, Marie-Laure, Douarin, Ludivine, Uzun, Ievgeniia, El-Haddad, Chantal, Hurst, William, Juhaeri, Juhaeri, Tcherny-Lessenot, Stéphanie
Formato: Artigo
Lenguaje:Inglês
Publicado: SAGE Publications 2020
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Acceso en línea: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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