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网络释义 1. 分析方法的验证 CTD_百度文库 ... S.4.3Validation of Analytical Procedures分析方法的验证3.2. S.4.4 Batch Analyses 批分析 3.2. ... wenku.baidu.com|基于12个网页 2. 分析方法验证 200506... ... Concerned Network 相关网络Validation of Analytical Procedures分析方法验证OMCL 质量管理体系审...
validation of频次较高,且没有表达出质量管理相关含义,因此继续以validation为节点,节点两端8个单词的跨度比对后发现,validation多与“分析方法(validation of analytical procedures)”及“工艺(process validation)”组成与质量管理相关的词组,且出现频次较高。 3.validation的语义及规范化译名分析 表1表明validation翻译为...
Validation of analytical procedures, Proceeding of the International Conference of Harmonisation (ICH), Commission of the European Communities (2009)of pharmaceutical sciences. 7. ICH topic Q2A. "Validation of analytical procedures": Text (1996). 8. ICH topic Q2B. "Validation of analytical ...
validation_of_analytical_proceduresEDQM分析方法学验证 系统标签: validationanalyticaledqmproceduresomcl分析方法 OMCLNetworkoftheCouncilofEuropeGENERALDOCUMENTPA/PH/OMCL(13)822RVALIDATIONOFANALYTICALPROCEDURESFulldocumenttitleandreferenceValidationofAnalyticalProceduresPA/PH/OMCL(13)822RDocumenttypeGuidelineLegislativebasis...
Although there are many other analytical procedures, such as dissolution testing for drug products or particle size determination for drug substance, these have not been addressed in the initial text on validation of analytical procedures. Validation of these additional analytical procedures is equally ...
Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability and consistency of analytical resul
Page 4 of 32 Compendium of Analytical Procedures CAP007/03 4. 4.1 GLOSSARY OF TERMS Validation Tests Tests done to show that the method is scientifically sound and adequate for the intended use. 4.2 Analytical Method The analytical method refers to the way of performing the analysis. It should...
VALIDATION OF ANALYTICAL PROCEDURES Full document title and reference Validation of Analytical Procedures PA/PH/OMCL (13) 82 2R Document type Guideline Legislative basis The present document was also accepted by EA as recommendation document to be used in the context of Quality Management System ...