药品注册的国际技术要求 2007安全性部分PDF电子书下载

S1A　药物致癌试验必要性的指导原则 1

S1B　药物致癌试验 8

S1C（R）　药物致癌试验的剂量选择和剂量限度 19

S2A　药物审评遗传毒性试验的特殊性指导原则 31

S2B　遗传毒性：药物遗传毒性试验标准组合 45

S3A　毒物代谢动力学（毒代动力学）指导原则：毒性研究中全身暴露的评价 56

S3B　药物代谢动力学（药代动力学）：重复给药的组织分布研究指导原则 71

S4　动物（啮齿类和非啮齿类）慢性毒性试验的期限 75

S5（R2）　药品的生殖毒性检测和雄性生育力毒性 78

S5B　雄性生育力毒性ICH指导原则 103

S6　生物技术药物的临床前安全性评价 109

S7A　人用药物安全药理学研究指导原则 123

S7B　人用药延迟心室复极化（QT间期延长）潜在作用的非临床评价指导原则 137

S8　人用药物免疫毒性研究 151

M3（R1）　支持药物进行临床试验的非临床安全性研究 166

S1A　GUIDELINE ON THE NEED FOR CARCINOGENICITY STUDIES OF PHARMACEUTICALS 178

S1B　TESTING FOR CARCINOGENICITY OF PHARMA-CEUTICALS 188

S1C(R1)　DOSE SELECTION FOR CARCINOGENICITY STUDIES OF PHARMACEUTICALS ＆ LIMIT DOSE 204

S2A　GUIDANCE ON SPECIFIC ASPECTS OF REGULATORY GENOTOXICITY TESTS FOR PHARMACEUTICALS 224

S2B　GENOTOXICITY:A STANDARD BATTERY FOR GENOTOXICITY TESTING OF PHARMACEUTICALS 248

S3A　NOTE FOR GUIDANCE ON TOXICOKINETICS:THE ASSESSMENT OF SYSTEMIC EXPOSURE IN TOXICITY STUDIES 265

S3B　PHARMACOKINETICS:GUIDANCE FOR REPEATED DOSE TISSUE DISTRIBUTION STUDIES 288

S4 DURATION OF CHRONIC TOXICITY TESTING IN ANIMALS (RODENT AND NON RODENT TOXICITY TESTING) 294

S5(R2)　DETECTION OF TOXICITY TO REPRODUCTION FOR MEDICINAL PRODUCTS ＆ TOXICITY TO MALE FERTILITY 299

PART Ⅰ:DETECTION OF TOXICITY TO REPRODUCTION FOR MEDICINAL PRODUCTS 303

PART Ⅱ:TOXICITY TO MALE FERTILITY 332

S6 PRECLINICAL SAFETY EVALUATION OF BIOTECHNOLOGY-DERIVED PHARMACEUTICALS 339

S7A SAFETY PHARMACOLOGY STUDIES FOR HUMAN PHARMACEUTICALS 360

S7B THE NON-CLINICAL EVALUATION OF THE POTENTIAL FOR DELAYED VENTRICULAR REPOLARIZATION(QT INTERVAL PROLONGATION) BY HUMAN PHARMACEUTICALS 380

S8 IMMUNOTOXICITY STUDIES FOR HUMAN PHARMACEUTICALS 399

M3(R1) MAINTENANCE OF THE ICH GUIDELINE ON NON-CLINICAL SAFETY STUDIES FOR THE CONDUCT OF HUMAN CLINICAL TRIALS FOR PHARMACEUTICALS 421