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 · 2020/8/101 分で読めます
Drug-Drug Interaction Assessment for Therapeutic Proteins; Draft Guidance for Industry; Availability
ローカル自動翻訳 · 情報源の原言語
概要
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Drug-Drug Interaction Assessment for Therapeutic Proteins." The purpose of this guidance is to provide a systematic, risk-based approach to help sponsors of investigational new drug applications (INDs) and applicants of biologic license applications (BLAs) determine the need for drug- drug interaction (DDI) studies for a therapeutic protein (TP).
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →