S1A 药物致癌试验必要性的指导原则 1
S1B 药物致癌试验 9
S1C 药物致癌试验的剂量选择 21
S1C’药物致癌试验剂量选择指导原则附件：补充剂量限度和有关注释 33
S2A 药物审评遗传毒性试验的特殊性指导原则 37
S2B 遗传毒性：药物遗传毒性试验标准组合 51
S3A 毒代动力学指导原则：毒性研究中全身暴露的评价 63
S3B 药代动力学：重复给药的组织分布研究指导原则 79
S4 动物慢性毒性试验的周期(啮齿类和非啮齿类) 83
S5A 药品的生殖毒性检测 87
S5B 对雄性生育力毒性 115
S6 生物技术药物的临床前安全性评价 121
M3 实施新药临床研究所需非临床安全性试验的时间安排 135
S1A Guideline on the need for carcinogenicity studies of pharmaceuticals 149
S1B Testingfor carcinogenicity of pharmaceuticals 159
S1C Dose selection for carcinogenicity studies of pharmaceuticals 175
S1C' Addendum to“dose selection for carcinogen-icity studies of pharmaceuticals”：addition of a limit dose and related notes 191
S2A Guidance on specific aspects of regulatory genotoxicity tests for pharmaceuticals 195
S2B Genotoxicity：a standard battery for genotox-icity testing of pharmaceuticals 219
S3A Note for guidance on toxicokinetics：the assessment of systemic exposure in toxicity studies 235
S3B Pharmacokinetics：guidance for repeated dose tissue distribution studies 257
S4 Duration of chronic toxicity testing in animals(rodent and non rodent toxicity testing) 263
S5A Detection of toxicity to reproduction for medicinal products 267
S5B Toxicity to male fertility：an addendum to the ICH tripartite guideline on detection of toxicity to reproduction for medicinal products 301
S6 Preclinical safety evaluation of biotechnology-derived pharmaceuticals 309
M3 Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals 331
ICH安全性领域专业术语表 347