この記事の翻訳を準備しています。それまでの間、英語の原文を表示します。
ビジネス · 2026/1/121 分で読めます
Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products; Draft Guidance for Industry; Availability
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概要
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products."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.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →