ICH指导原则 - 蒲标网

Safety Guidelines
安全性

编号	阶段	内容
S1A	Step 5	Need for Carcinogenicity Studies of Pharmaceuticals 药物致癌试验的必要性
S1B	Step 5	Testing for Carcinogenicity of Pharmaceuticals 药物致癌试验
S1C(R2)	Step 5	Dose Selection for Carcinogenicity Studies of Pharmaceuticals 药物致癌试验的剂量选择
S2(R1)	Step 5	Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use 人用药物的遗传毒性试验和数据分析指导原则
S3A	Step 5	Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies 毒代动力学指导原则：毒性研究中全身暴露的评价
S3A Q&As	Step 3	Questions and Answers: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure - Focus on Microsampling S3A问与答
S3B	Step 5	Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies 药代动力学：重复给药的组织分布研究指导原则
S4	Step 5	Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing) 动物慢性毒性试验的周期（啮齿类和非啮齿类）
S5(R2)	Step 5	Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility 药物生殖毒性和雄性生育力毒性的检测
S6(R1)	Step 5	Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals 生物技术药品的临床前安全性试验
S7A	Step 5	Safety Pharmacology Studies for Human Pharmaceuticals 人用药物的安全性药理学研究
S7B	Step 5	The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals 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
S8	Step 5	Immunotoxicity Studies for Human Pharmaceuticals 人用药品的免疫毒性研究
S9	Step 5	Nonclinical Evaluation for Anticancer Pharmaceuticals 抗癌药物的非临床评价
S9 Q&As	Step 3	Questions and Answers: Nonclinical Evaluation for Anticancer Pharmaceuticals 抗癌药物非临床评价的问与答
S10	Step 5	Photosafety Evaluation of Pharmaceuticals 药物的光安全性评价
S11	Step 1	Nonclinical Safety Testing in Support of Development of Paediatric Medicines 支持儿科药物研发的非临床研究

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