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要 約
FDA Guidance Document (旧:Guides #65)
FDA Guidance #64
Q1A(R2): 新医薬品原薬、および製剤の安定性試験
Guidance for Industry Q1A(R2): Stability Testing of New Drug Substances and Products (November 2003, ICH Revision 2 )

Guidance for Industry
Q1A(R2) : Stability Testing of New Drug Substances and Products
Q1A(R2): 新医薬品原薬、および製剤の安定性試験
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research(CDER)
Center for Biologics Evaluation and Research(CBER)
November 2003
ICH
Revision 2
目次[Table of Contents]
I.緒論[Introduction] (1)
 A.ガイダンスの目的[Objectives of the Guidance] (1.1)
 B.ガイダンスの範囲[Scope of the Guidance] (1.2)
 C.一般的原則[General Principles] (1.3)
II.ガイダンス[Guidance] (2)
 A.医薬品原薬[Drug Substance] (2.1)
  1.一般的事項[General] (2.1.1)
  2.過酷試験[Stress Testing] (2.1.2)
  3.バッチの選択[Selection of Batches] (2.1.3)
  4.容器・蓋栓システム[Container Closure System (2.1.4)
  5.規格[Specification] (2.1.5)
  6.試験頻度[Testing Frequency] (2.1.6)
  7.保管条件[Storage Conditions] (2.1.7)
  8.安定性に関する誓約[Stability Commitment] (2.1.8)
  9.評価[Evaluation] (2.1.9)
  0.製品説明書/表示[Statements/Labeling] (2.1.10)
 B.医薬品製剤[Drug Product] (2.2)
  1.一般的事項[General] (2.2.1)
  2. 光安定性[Photostability Testing] (2.2.2)
  3.バッチの選択[Selection of Batches] (2.2.3)
  4.容器・蓋栓システム[Container Closure System (2.2.4)
  5.規格[Specification] (2.2.5)
  6.試験頻度[Testing Frequency] (2.2.6)
  7.保管条件[Storage Conditions] (2.2.7)
  8.安定性に関する誓約[Stability Commitment] (2.2.8)
  9.評価[Evaluation] (2.2.9)
  10.製品説明/表示[Statement/Labeling](2.2.10)
用語の語彙[Glossary] (3)
参考資料[References] (4)
付属資料: 改訂 2 の変更内容リスト[List of Revision 2 Changes]



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