Safety Guidelines
安全性
编号阶段内容
S1AStep 5Need for Carcinogenicity Studies of Pharmaceuticals
药物致癌试验的必要性
S1BStep 5Testing for Carcinogenicity of Pharmaceuticals
药物致癌试验
S1C(R2)Step 5Dose Selection for Carcinogenicity Studies of Pharmaceuticals
药物致癌试验的剂量选择
S2(R1)Step 5Guidance 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
S3AStep 5Note 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&AsStep 3Questions and Answers: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure - Focus on Microsampling
S3A问与答
S3BStep 5Pharmacokinetics: 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
S4Step 5Duration 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 5Detection 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 5Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
生物技术药品的临床前安全性试验
S7AStep 5Safety Pharmacology Studies for Human Pharmaceuticals
人用药物的安全性药理学研究
S7BStep 5The 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
S8Step 5Immunotoxicity Studies for Human Pharmaceuticals
人用药品的免疫毒性研究
S9Step 5Nonclinical Evaluation for Anticancer Pharmaceuticals
抗癌药物的非临床评价
S9 Q&AsStep 3Questions and Answers: Nonclinical Evaluation for Anticancer Pharmaceuticals
抗癌药物非临床评价的问与答
S10Step 5Photosafety Evaluation of Pharmaceuticals
药物的光安全性评价
S11Step 1Nonclinical 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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