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...
Main Authors: | , , , , , , |
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Format: | Article |
Language: | English |
Published: |
SAGE Publishing
2020-12-01
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Series: | Therapeutic Advances in Drug Safety |
Online Access: | https://doi.org/10.1177/2042098620976951 |