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 · 2016/6/141 分で読めます
Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment; Draft Guidance for Industry; Availability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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment." This draft guidance provides recommendations to industry for designing a nonclinical development program to support approval of drugs to treat osteoporosis. This guidance also discusses the nonclinical development of biopharmaceuticals (e.g., recombinant proteins and monoclonal antibodies).
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →