5、Q2 Analytical Validation分析验证分析验证Q2(R1)Validation of Analytical Procedures: Text and Methodology分析程序的验证:正文及方法论a7Q3A - Q3D Impurities杂质杂质Q3A(R2) Impurities in New Drug Substances新原料药中的杂质Q3B(R2) Impurities in New Drug Products新制剂中的杂质Q3C(R5) Impurities: Guide...
Q1F: Stabilitiy Guidelines_WHO Q1F:WHO稳定性指导原则 2009 Q2 Analytical Validation/分析方法验证 Q2(R1): Validation of Analytical Procedures Text and Methodology Q2(R1): 分析过程和方法的确证 2005.11 Q3A - Q3D Impurities/杂质 Q3A(R2): Impurities in New Drug Substances Q3A(R2): 新型原料药中的杂...
ZonesIIIandIV在气候带III和IV，药物注册申请所提供旳稳定性数据 Q2AnalyticalValidation分析验证 Q2(R1)ValidationofAnalyticalProcedures:TextandMethodology分析程序旳验证：正文及措施论 Q3A-Q3DImpurities杂质 Q3A(R2)ImpuritiesinNewDrugSubstances新原料药中旳杂质Q3B(R2)ImpuritiesinNewDrugProducts新制剂中旳杂质Q3C(R5)...
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 Products (Revised Guideline) 新制剂中的杂质(修订版) Q3C: Impurities: Guideline for Residual Solvents 杂质:残留溶剂指南 Q3C(M): Impurities: Guideline for Residual Solvents...
Q1F: Stabilitiy Guidelines_WHO Q1F:WHO稳定性指导原则 2009 Q2 Analytical Validation/分析方法验证 Q2(R1): Validation of Analytical Procedures Text and Methodology Q2(R1): 分析过程和方法的确证 2005.11 Q3A - Q3D Impurities/杂质 Q3A(R2): Impurities in New Drug Substances Q3A(R2): 新型原料药中的...
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 Products (Revised Guideline) 新制剂中的杂质(修订版) Q3C: Impurities: Guideline for Residual Solvents 杂质:残留溶剂指南 Q3C(M): Impurities: Guideline for Residual Solvents...
―E‖类专题——EfficacyGuidelines―M‖类专题——MultidisciplinaryGuidelines ICH简介 •名称2015.10.23更名为：InternationalCouncilforHarmonisationofTechnicalRequirementsforPharmaceuticalsforHumanUse（ICH）人用药物技术要求国际协调理事会 曾用名：InternationalConferenceonHarmonisationofTechnicalRequirementsfor...
Q3A(R2) Step 5 2006-10-25 Impurities in New Drug Substances 新原料药中的杂质 Q3B(R2) Step 5 2006-6-2 Impurities in New Drug Products 新药制剂中的杂质 Q3c(R6) Step 5 2016-10-20 Impurities: Guideline for Residual Solvents Q3D Step 5 2014-12-16 Guideline for Elemental Impurities Q4 ...
M7(R1)旨在补充ICH Q3A（R2）、Q3B（R2）和ICH M3（R2）的指导原则，强调在保证安全性和质量风险管理的情况下，制定致突变杂质的限度来控制致癌风险。此指导原则适用于评估和控制原料药或制剂中残留或可能残留的致突变杂质，并考虑用药人群的具体情况。2020版中国药典添加了《9306遗传毒性杂质控制指导原则...
Q3A(R2): Impurities in New Drug Substances Q3A(R2):新原料药中的杂质 阶段5 2006.10.25 有 Q3B(R2): Impurities in New Drug Products Q3B(R2):新药制剂中的杂质 阶段5 2006.6.2 有 Q3C(R8) Impurities:Guideline for Residual Solvents Q3C(R8):杂质:残留溶剂的指导原则 阶段5 2021.4.22 有 Q3...