| 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5 |
1997.7.16 |
有 |
| S1B（R1）：TESTING FOR CARCINOGENICITY OF PHARMACEUTICALS |
S1B（R1）：药物致癌性试验 |
阶段4 |
2022.8.4 |
有 |
| S1C(R2): Dose 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 Use |
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 Assessment 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 |
1994.10.27 |
有 |
| S3A Implementation Working Group Questions and Answers |
S3A问答：毒代动力学指导原则说明：毒性研究中的全身暴露量评价问答 |
阶段3 |
2016.1.19 |
有 |
| S3B: Pharmacokinetics Guidance for Repeated Dose 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 |
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）：药品的生殖毒性和雄性生育力毒性检测 |
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 |
阶段5 |
2020.2.18 |
有 |
| 6 |
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 |
有 |
| 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 |
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 |
|
S11:Nonclinical Safety Testing In Support of Development of Paediatric Pharmaceuticals |
S11：支持儿科药物开发的非临床安全性评价 |
阶段5 |
2020.4.14 |
有 |
| 12 |
S12：Nonclinical Biodistribution Considerations For Gene Therapy Products/基因治疗产品非临床生物分布的考虑 |
|
S12：Nonclinical Biodistribution Considerations For Gene Therapy Products |
S12：基因治疗产品非临床生物分布的考虑 |
阶段5 |
2023.3.14 |
有 |
