ICH方法学验证.pdf,Guidance for Industry Q2B Validation of Analytical Procedures: Methodology November 1996 ICH Guidance for Industry Q2B Validation of Analytical Procedures: Methodology Additional copies are available from: the Drug Information Branch (H
(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) ...
(R1)Newtitle:ValidationofAnalyticalProcedures:TextandMethodologyPreviously:TextonValidationofAnalyticalProceduresQ2AValidationofAnalyticalProcedures:Methodology(inQ2(R1))Q2BImpuritiesQ3A(R2)ImpuritiesinNewDrugSubstancesQ3A(R)Q3B(R2)ImpuritiesinNewDrugProductsQ3B(R)Q3C(R3)Impurities:GuidelineforResidualSolventsQ3C...
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|21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...