药品注册的国际技术要求 中英对照 安全性部分PDF格式文档图书下载

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

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