人用药品注册技术要求国际协调会(ICH)简介 1
Q1a 新原料药和制剂的稳定性试验 1
Q1b 稳定性试验：新原料药和制剂的光稳定性试验 17
Q1c 稳定性试验：新剂型的要求 29
Q2a 分析方法论证的文本 31
Q2b 分析方法的论证：方法学 39
Q3a 新原料药中的杂质 53
Q3b 新药制剂中的杂质 67
Q3c 杂质：残留溶剂的指导原则 79
Q5a 生物技术产品的病毒安全性评价 101
Q5b 对用于生产rDNA来源蛋白质产品的细胞的表达构建体分析 137
Q5c 生物技术/生物制品质量：生物技术/生物制品稳定性试验 143
Q5d 用于生物技术产品及生物制品生产的细胞基质的来源和鉴定 155
Q6a 规范：新原料药和新药制剂的测试方法和认可标准：化学物质 175
Q6b 规范：生物技术产品及生物制品的测试方法和认可标准 215
Q1a Stability testing of new drug substances and products 239
Q1b Stability testing：photostability testing of new drug substances and products 263
Q1c Stability testing：requirements for new dosage forms 279
Q2a Text on validation of analytical procedures 283
Q2b Validation of analytical procedures：methodology 291
Q3a Impurities in new drug substances 307
Q3b Impurities in new drug products 325
Q3c Impurities：guideline for residual solvents 343
Q5a Viral safety evaluation of biotechnology products 369
Q5b Quality of biotechnological products：analysis of the expression construct in cells used for production of R-DNA derived protein products 419
Q5c Quality of biotechnological products：stability testing of biotechnological/biological products 429
Q5d Derivation and characterisation of cell substrates used for production of biotechnological/biological products 447
Q6a Specifications：test procedures and acceptance criteria for new drug substances and new drug products：chemical substances 473
Q6b Specifications：test procedures and acceptance criteria for biotechnological/biological products 525
中英文对照术语表 559