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 本指导原则的目标 本指导原则为ICH S2A和S2B指导原则的替代和合并。 本次修订的目的是:优化预测潜在人体风险的遗传毒性试验 标准组合;为结果分析提供指导...
S2(R1): Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use S2(R1): 关于人用药基因毒性试验和数据解读的指导原则 2011.11.9 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...
21、s s1c(r2) dose selection for carcinogenicity studies of pharmaceuticals s2 genotoxicity studies遗传毒性研究 s2(r1) guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human uses2a: guidance on specific aspects of regulatory genotoxicity tests for pharmaceuticals; s2...
1.S1A:GuidelineontheNeedforCarcinogenicityStudiesofPharmaceuticals 药物致癌试验的必要性 2.S1B:TestingforCarcinogenicityofPharmaceuticals 药物致癌试验 3.S1C(R2):DoseSelectionforCarcinogenicityStudiesofPharmaceuticals 药物致癌试验的剂量选择 S2 Genotoxicity Studies遗传毒性 4.S2(R1):GuidanceonGenotoxicityTestingandDa...
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): 关于人用药基因毒性试验和数据解读的指导原则 2011.11.9 S3A - S3B Toxicokinetics and Pharmacokinetics/毒代动力学和药代动力学 ...
S2(R1):GuidanceonGenotoxicityTestingandDataInterpretationforPharmaceuticalsIntendedforHumanUse 人用药物的遗传毒性试验和数据分析指导原则 S3A-S3B:ToxicokineticsandPharmacokinetics毒物代谢动力学与药物代谢动力学 S3A:NoteforGuidanceonToxicokinetics:TheAssessmentofSystemicExposureinToxicityStudies 毒物代谢动力学指南的注释:...
(r2) dose selection for carcinogenicity studies of pharmaceuticals 药物致 癌试验的剂量选择 4.s1c 药物致癌试验的剂量选择的附件:补充剂量限度和有关注释 遗传毒 性 5.s2(r1) 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...
S2(R1) Step 5 2011-11-09 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 S3 Toxicokinetics and Pharmacokinetics(毒代动力学和药代动力学) S3A Step 5 1994-10-27 Note for Guidance on Toxicokinetics: The...
•ICH简介 录 • ICH指导原则简介 “Q‖类专题——QualityGuidelines ―S‖类专题——SafetyGuidelines ―E‖类专题——EfficacyGuidelines―M‖类专题——MultidisciplinaryGuidelines ICH简介 •名称2015.10.23更名为：InternationalCouncilforHarmonisationofTechnicalRequirementsforPharmaceuticalsforHumanUse...
S2GenotoxicityStudies(遗传毒性研究) S3ToxicokineticsandPharmacokinetics(毒代动力学和药代动力学) S4ToxicityTesting(毒性试验) 1 S5ReproductiveToxicology(生殖毒性) S6BiotechnologicalProducts(生物技术药品) S7PharmacologyStudies(药理学研究) S8ImmunotoxicologyStudies(免疫毒性研究) ...