ICH Q1~9主要内容列表


ICH:Quality质量各块主要内容: Q1A(R2): Stability Testing of New Drug Substances and Products (Second Revision)

新原料药和制剂的稳定性试验(第二版) Q1B: Photostability Testing of New Drug Substances and Products

新原料药和制剂的光稳定性试验 Q1C: Stability Testing for New Dosage Forms

新制剂的稳定性试验 Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products 原料药和制剂稳定性试验的交叉和矩阵设计 Q1E: Evaluation of Stability Data

对稳定性数据的评估处理 Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV

在气候带III和IV,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 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 (Maintenance)


Q4: Pharmacopoeias药典

Q4A: Pharmacopoeial Harmonisation 药典的协调 Q4B: Regulatory Acceptance of Pharmacopoeial Interchangeability

药典互替在法规上的可接受性 Q5A: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin 来源于人或者动物细胞系的生物技术产品的病毒安全性评估 Q5B: Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products

生物技术产品的质量:源于重组DNA的蛋白质产品的生产中所用的细胞中的表达构建分析 Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products 生物技术产品的质量:生物技术/生物产品的稳定性试验

Q5D: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products

用于生产生物技术/生物产品的细胞底物的起源和特征描述 Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process 基于不同生产工艺的生物技术产品/生物产品的可比较性

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