资讯(10)日志(7)
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含量测定分析方法验证
uytdo 发表于 2010-05-17 10:29:02在进行质量研究的过程中,一项重要的工作就是要对质量标准中所涉及到的分析方法进行方法学验证,以保证所用的分析方法确实能够用于在研药品的质量控制。为规范对各种分析方法的验证要求,我国已于2005年颁布了分析方法验证...
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美国FDA分析方法验证指南中英文对照(六)
Helen123 发表于 2009-01-05 12:24:07XI. METHODOLOGYSections II through IX provide general information on the submission of analytical procedures and methods validation information, including validation characteristics. Additional inform...
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美国FDA分析方法验证指南中英文对照(五)
Helen123 发表于 2009-01-05 12:18:21VIII. STATISTICAL ANALYSIS A. General Methods validation includes an assessment of the adequacy of the analytical procedure. Statistical analysis (e.g., linear regression analysis, relative standard d...
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美国FDA分析方法验证指南中英文对照(四)
Helen123 发表于 2009-01-05 11:34:48VII. METHODS VALIDATION FOR NDAs, ANDAs, BLAs, AND PLAs A. Noncompendial Analytical Procedures In an NDA, ANDA, BLA, or PLA, data must be submitted to establish that the analytical procedures used in ...
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美国FDA分析方法验证指南中英文对照(三)
Helen123 发表于 2009-01-05 10:58:48VI. CONTENT AND FORMAT OF ANALYTICAL PROCEDURES FOR NDAs, 230ANDAs, BLAs, AND PLAsAny analytical procedure submitted in an NDA, ANDA, BLA, or PLA should be described in sufficient detail to allow a co...
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美国FDA分析方法验证指南中英文对照(二)
Helen123 发表于 2009-01-05 10:44:15III. TYPES OF ANALYTICAL PROCEDURES A. Regulatory Analytical Procedure A regulatory analytical procedure is the analytical procedure used to evaluate a defined characteristic of the drug substance o...
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美国FDA分析方法验证指南中英文对照(一)
Helen123 发表于 2009-01-05 10:38:15美国FDA分析方法验证指南中英文对照(http://www.drugfuture.com/library/ShowArticle.asp?ArticleID=69)I. INTRODUCTIONThis guidance provides recommendations to applicants on submitting analytical procedures, ...
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