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Table of Contents
第1部 E&L（Extractabels & Leachables：抽出物・浸出物）における欧米の規制要件とその動向
第1章 ICH-Q3E：医薬品及び生物製剤の
E&L（Extractabels & Leachables：抽出物・浸出物）ガイドライン作成の背景とポイント
はじめに
1. ICH-Q3E 以前の状況
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- Material Type
- 図書
- ISBN
- 978-4-86428-340-3
- Title Transcription
- オウベイ キセイ / ICH Q3E オ フマエタ E&L (Extractables & Leachables) シケン ノ ブンセキ シュホウ ・ アンゼンセイ ヒョウカ / カンリ イキチ ト リスク カンリ
- Publication, Distribution, etc.
- Publication Date
- 2025.5
- Publication Date (W3CDTF)
- 2025
- Extent
- 137 p
- Size
- 26 cm
- Place of Publication (Country Code)
- JP