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Entreprise · 12/01/20261 min de lecture
Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products; Draft Guidance for Industry; Availability
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Résumé
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products." This document provides guidance on the appropriate use of Bayesian methods in clinical trials. The primary focus is on the use of Bayesian methods to support primary inference in pivotal clinical trials designed to support the effectiveness and safety of drug and biological products.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →