図書

分析法バリデーション事例集 : 製剤/原薬・TK/PK別

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分析法バリデーション事例集 : 製剤/原薬・TK/PK別

Call No. (NDL)
SD61-J39
Bibliographic ID of National Diet Library
000010439876
Material type
図書
Author
情報機構
Publisher
情報機構
Publication date
2009.2(第2刷)
Material Format
Paper
Capacity, size, etc.
621p ; 27cm
NDC
499.33
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Detailed bibliographic record

Summary, etc.:

実際の分析法バリデーション事例を一挙公開。規制当局の考え方にも追求!(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 分析法バリデーション概要 —規制当局の考え方—

  • 1 分析法バリデーションの概要/ 3

  • 1-1 分析法バリデーションの役割と規格との整合性/ 3

  • 1-2 分析能パラメータとその評価の考え方/ 4

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Bibliographic Record

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Paper

Material Type
図書
ISBN
978-4-904080-00-9
Title Transcription
ブンセキホウ バリデーション ジレイシュウ : セイザイ ゲンヤク TK PKベツ
Author Heading
情報機構 ジョウホウ キコウ ( 01171002 )Authorities
Publication, Distribution, etc.
Publication Date
2009.2(第2刷)
Publication Date (W3CDTF)
2009
Extent
621p
Size
27cm