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1 2) ガイドラインアネックス 13 和訳
別紙(1 2) PIC/S GMPガイドラインアネックス13 原文 和訳 MANUFACTURE OF INVESTIGATIONAL 治験薬の製造 MEDICINAL PRODUCTS lnvestigational medicinal products should be 治験薬は医薬品GMPの原員lj と詳細ガイドフインを遵 produced in accordance with the principles and the 守して製造すること。
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INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER FOR, 2009 06 annex13, Product, Investigational, Investigational medicinal product, European Medicines Agency Inspections, Investigational Medicinal, EU GMP Requirements, OECD Recommendation on the Governance of, Dossier, NATIONAL DRUG AUTHORITY, Current Global GMP Status and Trends