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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...
Autores principales: | Kürzinger, Marie-Laure, Douarin, Ludivine, Uzun, Ievgeniia, El-Haddad, Chantal, Hurst, William, Juhaeri, Juhaeri, Tcherny-Lessenot, Stéphanie |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
SAGE Publications
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7727082/ https://www.ncbi.nlm.nih.gov/pubmed/33343857 http://dx.doi.org/10.1177/2042098620976951 |
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