Structured benefit-risk evaluation for medicinal products: review of quantitative benefit-risk assessment findings in the literature

• Main Authors: Marie-Laure Kürzinger (Author), Ludivine Douarin (Author), Ievgeniia Uzun (Author), Chantal El-Haddad (Author), William Hurst (Author), Juhaeri Juhaeri (Author), Stéphanie Tcherny-Lessenot (Author)
• Format: Book
• Published: SAGE Publishing, 2020-12-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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&quo...