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 · 1998/6/81 分で読めます
Draft Guidance for Industry on Stability Testing of Drug Substances and Drug Products; Availability
ローカル自動翻訳 · 情報源の原言語
概要
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Stability Testing of Drug Substances and Drug Products.'' The draft guidance provides recommendations regarding the stability studies that should be performed to support new drug applications, abbreviated new drug applications, investigational new drug applications, biologics license applications, product license applications, and supplements to these applications.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →