Q6 Specifications (质量标准) Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Q6A Step 5 1999-10-6 Products: Chemical Substances 质量标准 新原料药和制剂的检 测以及可接受标准:化学物质 Specifications : Test Q6B Step 5 1999-3-10 Procedures and ...
ICH关于Q8、Q9和Q10的问与答(R4)Q8Q9Q10R4 现行版本 2010年11月11日
6Q6A- Q6B Specifications/规格 Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical SubstancesQ6A:质量标准:新原料药和新药制剂的检测方法和可接受标准:化学药物阶段51999.10.6有 Q6B: Specifications: Test Procedures and Acceptance Criteria for ...
Q6质量原则Q6A规范:新原料药和新制剂旳测试办法和承认原则:化学物质Q6B规范:生物技术产品及生物制品旳测试办法和承认原则 第8页ICH指引原则概述ICH质量部分内容 Q7药物活性成分旳GMP指南Q8药物开发风险管理Q9质量风险管理Q10制药质量体系Q11原料药旳研发与生产Q12药物生命周期管理旳技术和法规考虑(202023年9月发布) 第9...
Q6B Specifications规格 Q6A Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances质量规格:新原料 药和新制剂的检验程序和可接收标准:化学物质( 包括决定过程) Q6B Specifications : Test Procedures and Acceptance Criteria for Biotechnological/...
Reference ICH Guidelines: Q6A and Q6B 参照ICH 指南:Q6A 和Q6B 3.2.S.2 Manufacture (name, manufacturer) 3.2.S.2 生产(名称,厂商) 3.2.S.2.1 Manufacturer(s) (name, manufacturer) 3.2.S.2.1 厂商(名称、厂商) The name, address, and responsibility of each manufacturer, including contractors, and...
2. Scope This guideline is applicable to drug substances as defined in the Scope sections of ICH Guidelines Q6A and Q6B, but might also be appropriate for other types of products following consultation with the appropriate regulatory authorities. It is particularly relevant to the preparation and ...
最ICH指导建议建议原则专家讲座第10页Q6A-Q6BSpecifications规格Q6ASpecifications:TestProceduresandAcceptanceCriteriaforNewDrugSubstancesandNewDrugProducts:ChemicalSubstances质量规格:新原料药和新制剂检验程序和可接收标准:化学物质(包含决定过程)Q6BSpecifications:TestProceduresandAcceptanceCriteriaforBiotechnological/BiologicalPr...
ICH Q11中文版
ICH Q11 is applicable to drug substances as defined in the Scope sections of ICH guidelines 8 Q6A and Q6B, but might also be appropriate for other types of products following consultation with the appropriate regulatory authorities. ICH Q11 9 does not apply to contents of submissions during the...