范国荣化学药物质量及质量标准制订技术总结.ppt

新药的药学评价——化学药物质量研究及质量标准制订 第二军医大学药学院 范国荣 guorfan@ 药品安全事件 “齐二药”事件：急性肾衰 亮菌甲素注射液 辅料“丙二醇”实际为“二甘醇” 安徽华源“欣弗” 事件：急性肝坏死 克林霉素磷酸酯葡萄糖注射液 违规生产 相关技术指导原则(ICH) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human use 人用药品注册技术要求国际协调会（欧盟、美国、日本三方） International Conference on Harmonisation-Quality 质量方面的技术文件，共23个，以Q表示 Q1A(R2) Stability Testing of New Drug Substances and Products 新原料药及制剂稳定性 Q1B Photostability Testing of New Drug Substances and Products 新原料药及制剂光稳定性 Q1C Stability Testing For New Dosage Forms: annex to the ICH Harmonised Tripartite Guideline on Stability Testing for New Drugs and Products 新剂型的稳定性试验分析方法验证 Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products 新原料药和制剂稳定性试验的括号设计法和矩阵设计法 Q1E Evaluation for Stability Data 稳定性数据评价 Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV 气候带III和IV注册用稳定性研究 Q2A Text on Validation of Analytical Procedures? 分析方法验证的文本 Q2B Validation of Analytical Procedures: Methodology? 分析方法的论证：方法学 Q3A(R) Impurities in New Drug Substances 新原料药杂质要求 Q3B(R) Impurities in New Drug Products (Revision 2) 新制剂的杂质要求 Q3C Impurities: Guideline for Residual Solvents 溶剂残留量的指导原则 Q4 Evaluation and Recommendation ofPharmacopoeial Texts for Use in the ICH Regions药典相关内容 Q5A Viral Safety Evaluation Of Biotechnology Products Derived From Cell Lines Of Human Or Animal Origin 病毒安全性评价 Q5B Analysis of the Expression Construct in Cells used for Production of r-DNA Derived Protein Products 遗传稳定性评价 Q5C Quality of Biotechnological Products:Stability Testing of Biotechnological/Biological Products生物制品的稳定性试验 Q5D Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products 细胞基质的质量要求 Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process 生物技术/生物制品在生产工艺变更前后的可比性 Q6A Specifications: Test Proc