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要 約
FDA Guidance Document (旧:Guides #54)
FDA Guidance #52
Q1B 新規原薬、および製剤の光安定性試験
Guidance for Industry Q1B: Photostability Testing of New Drug Substances and Products (November 1996; ICH)

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research
June 2009
Office of Generic Drugs
Revision 1
Guidance for Industry
ANDAs : Impurities in Drug Substances
簡略医薬品承認申請:医薬品原薬中の不純物
目次[Table of Contents]
I.緒論[Introduction]
II.背景[Background]
III.不純物のリスティング、および医薬品原薬中の不純物の許容判定基準の設定[Listing of Impurities and setting Acceptance Criteria for Impurities in Drug Substance Specifications]
 A.医薬品原薬規格中の不純物のリスティング[Listing of Impurities in Drug Substance Specifications]
 B.不純物の許容判定基準の設定[Setting Acceptance Criteria for Impurities]
IV.不純物の格付け[Qualification of Impurities]
 A.格付け閾値[Qualification Thresholds]
 B.格付け手順[Qualification Procedures]
  1.比較分析試験[Comparative Analytical Studies]
  2.科学的文献、および重要な代謝物質[Scientific Literature and Significant Metabolites]
  3.毒性試験[Toxicity Studies]
添付資料Ⅰ:原薬中の不純物の確認、および格付け[Attachment Ⅰ - Identification and Qualification of Impurities in Drug Substances]



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