序号 | 英文题目 | 中文译文 | 阶段 | 发布时间 | 是否有中文译稿 |
1 | S1A - S1C Carcinogenicity Studies/致癌性研究 |
| S1A: Need for Carcinogenicity Studies of Pharmaceuticals | S1A：药物致癌性试验必要性指导原则 | 阶段5 | 1995.11.29 | 有 |
S1B: Testing for Carcinogenicity of Pharmaceuticals | S1B：药物致癌性试验 | 阶段5whatever will be will be | 1997.7.16 | 有 |
S1C(R2): Do Selection for Carcinogenicity Studies of Pharmaceuticals | S1C(R2)：药物致癌性试验的剂量选择 | 阶段5 | 2008.3.11 | 有 |
2 | S2 Genotoxicity Studies/基因毒性研究 |
| S2(R1): Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human U | S2(R1)：人用药物遗传毒性试验和结果分析指导原则 | 阶段5 | 2011.11.9 | 有 |
3 | S3A - S3B Toxicokinetics and Pharmacokinetics/毒代动力学和药代动力学 |
| S3A: Note for Guidance on Toxicokinetics: The Asssment of Systemic Exposure in Toxicity Studies | S3A：毒代动力学指导原则说明：毒性研究中的全身暴露量评价 | 阶段5 | make the change 1994.10.27 | 有 |
S3A Implementation Working Group Questions and Answers | S3A 问答 毒代毒代动力学指导原则说明：毒性研究中的全身暴露量评价-聚焦于微量采样 | 阶段3 | 2016.1.19 | 有 |
S3B: Pharmacokinetics Guidance for Repeated Do Tissue Distribution Studies | S3B：药代动力学：重复给药的组织分布研究指导原则 | 阶段5 | 星尚今日印象1994.10.27 | 有 |
4 | S4 Toxicity Testing/毒性试验 |
| S4: Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing) | S4：动物慢性毒性试验的期限（啮齿类和非啮齿类） | 阶段5 | 1998.9.2 | 有 |
5 | S5 Reproductive Toxicology/生殖毒性 |
| S5(R2):Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility | S5(R2): 检测药品的生殖毒性以及对雄性生殖能力的毒性 | 阶段5 | 2000.11 | 有 |
S5（R3）: Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals | S5(R3):人用药物生殖与发育毒性检测 heyi | 阶段5 | 2020.2.18 | 有 |
6 familyname | S6 Biotechnological Products/生物技术产品 |
| S6(R1): Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals | S6(R1)：生物制品的临床前安全性评价 | 阶段5 | 2011.6.12美国哈佛大学地址 | 有 上海翻译中心 |
7 | S7A - S7B Pharmacology Studies/药理学研究 |
| S7A: SAFETY PHARMACOLOGY STUDIES FOR HUMAN PHARMACEUTICALS | S7A：人用药品安全药理学试验指导原则 | 阶段5 | 2000.11.8 | 有 |
S7B: The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals | S7B：人用药品延迟心室复极化（QT间期延长）潜在作用的非临床评价指导原则 | 阶段5 | 2005.5.12 | 有 |
8 | S8 Immunotoxicology Studies 免疫毒理学研究 |
| S8: Immunotoxicity Studies for Human Pharmaceuticals | S8：人用药物免疫毒性研究 | 阶段5 | 2005.9.15 | 有 |
9 | S9 Nonclinical Evaluation for Anticancer Pharmaceuticals/抗癌药物的非临床评价 |
| S9: Nonclinical Evaluation for Anticancer Pharmaceuticals | S9：抗肿瘤药物非临床评价指导原则 | 阶段5 | 2009.10.29 | 英语口语交际有 |
S9 Implementation Working Group Questions and Answers | S9：抗肿瘤药物非临床评价指导原则问答 | 阶段3 | 2016.6.8 | 有 |
10 | S10 Photosafety Evaluation/光安全性评价 |
| S10: Photosafety Evaluation of Pharmaceuticals | S10：药物光安全评价 | 阶段5 | 2013.11.13 | 有 |
11 | S11 Nonclinical Safety Testing In Support of Development of Paediatric Pharmaceuticals/儿科用药 citricacid |
| S11:Nonclinical Safety Testing In Support of Development of Paediatric Pharmaceuticals | S11：支持儿科用药开发的非临床安全性评价 | 阶段5 | 2020.4.14 | 有我们和地球英文 |
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