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実務に役立つ治験薬管理における留意点

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実務に役立つ治験薬管理における留意点

Call No. (NDL)
SD61-M37
Bibliographic ID of National Diet Library
032109202
Material type
図書
Author
-
Publisher
情報機構
Publication date
2022.4
Material Format
Paper
Capacity, size, etc.
229 p ; 26 cm
NDC
499.4
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Detailed bibliographic record

Summary, etc.:

治験薬の製造品質管理やGCP省令下での管理および、再生医療等製品に関する最新規制を解説(Provided by: 出版情報登録センター(JPRO))

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Table of Contents

  • 目次

  • 第1章 治験薬の概要とバリデーションの考え方

  • 1.治験GMPの概要と基本コンセプト/ 3

  • 2.治験薬製造の考え方/ 4

  • 3.臨床試験に使用する原薬(ICH Q7 第19章)/ 6

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Paper

Material Type
図書
ISBN
978-4-86502-234-6
Title Transcription
ジツム ニ ヤクダツ チケンヤク カンリ ニ オケル リュウイテン
Publication, Distribution, etc.
Publication Date
2022.4
Publication Date (W3CDTF)
2022
Extent
229 p
Size
26 cm
Place of Publication (Country Code)
JP