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要 約
FDA Guidance Document
FDA Guidance #55(V-10)
簡略医薬品承認申請:医薬品製剤中の不純物
Guidance for Industry ANDAs:Impurities in Drug Products (November 2010 OGD)

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research
November 2010
OGD

Guidance for Industry
ANDAs : Impurities in Drug Products

簡略医薬品承認申請:医薬品製剤中の不純物

目次[Table of Contents]
I.緒論[Introduction]
II.背景[Background]
III.分解物のリスティング、および医薬品製剤中の分解物の許容判定基準の設定[Listing of Degradation Products and Setting Acceptance Criteria for Degradation Products in Drug Product Specifications]
 A.分解物のリスティング[Listing of Degradation Products]
 B.分解物の許容判定基準の設定[Setting Acceptance Criteria for Degradation Products]
IV.分解物の格付け[Qualification of Degradation Products ]
 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 Degradation Products in Generic Drug Products]



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