Q2A ValidationofAnalyticalProcedures:Methodology(inQ2(R1)) Q2B Impurities Q3A(R2) ImpuritiesinNewDrugSubstances Q3A(R) Q3B(R2) ImpuritiesinNewDrugProducts Q3B(R) Q3C(R3) Impurities:GuidelineforResidualSolvents Q3C Impurities:GuidelineforResidualSolvents(Maintenance) ...
(R1)New title: HYPERLINK /cache/compo/363-272-1.html \l Q2A#Q2A Validation of Analytical Procedures: Text and Methodology Previously: Text on Validation of Analytical ProceduresQ2A Validation of Analytical Procedures: Methodology (in Q2(R1))Q2B ImpuritiesQ3A(R2) ...
药物注册申请所提供的稳定性数据 Q2A: Text on Validation of Analytical Procedures 分析程序的验证 Q2B: Validation of Analytical Procedures: Methodology 分析程序的验证:方法学 Q3A(R): Impurities in New Drug Substances (Revised Guideline) 新原料药中的杂质(修订版) Q3B(R): Impurities in New Drug ...
Q2A:TextonValidationofAnalyticalProcedures 分析程序的验证 Q2B:ValidationofAnalyticalProcedures:Methodology 分析程序的验证:方法学 Q3A(R):ImpuritiesinNewDrugSubstances(RevisedGuideline) 新原料药中的杂质(修订版) Q3B(R):ImpuritiesinNewDrugProducts(RevisedGuideline) 新制剂中的杂质(修订版) Q3C:Impurities:Guide...
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ICH CTD格式介绍(中英文对照) .pdf ICH CTD格式介绍(中英文对照) ,国外认证流程 liuqinghua| 40页|396KB|22次下载| 4.8 (4人评价) 我要评价: 投诉举报 用手机看文档 下载 开通VIP INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE 人用药物...
degradation products (see ICH Q2A and Q2B guidelines on analytical validation). In particular, analytical procedures should be validated to demonstrate specificity for the specified and unspecified degradation products. As appropriate, this validation should include samples stored under relevant stress ...