22、notoxicity 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; S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceutical...
Moore MM, Honma M, Clements J, Bolcsfoldi G, Burlinson B, Cifone M et al. Mouse lymphoma thymidine kinase gene mutation assay: follow-up meeting of the international workshop on genotoxicity testing–Aberdeen, Scotland, 2003–Assay acceptance criteria, positive controls, and data evaluation. En...
一、QualityGuidelines质量研究指导原则 HarmonisationachievementsintheQualityareaincludepivotalmilestonessuchastheconductofstabilitystudies,definingrelevantthresholdsforimpuritiestestingandamoreflexibleapproachtopharmaceuticalqualitybasedonGoodManufacturingPractice(GMP)riskmanagement.Q1A-Q1FStability稳定性 Q1A(R2)StabilityTestingof...
S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals 基因毒性:药物基因毒性检验的标准 S3A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies 毒物代谢动力学指南的注释:毒性研究中的全身性暴露量的评估 S3B: Pharmacokinetics: Guidance for...
S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals 基因毒性:药物基因毒性检验的标准 S3A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies 毒物代谢动力学指南的注释:毒性研究中的全身性暴露量的评估 S3B: Pharmacokinetics: Guidance for...
In the years of use of the first ICH S2 guidelines, it has been recognised that the extreme focus on sensitivity for in vitro genotoxicity tests, as well as general improvements in various test systems, requires a revision of the principles of S2A and S2B. Thus, an ICH expert working ...
S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals 基因毒性:药物基因毒性检验的标准 S3A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies 毒物代谢动力学指南的注释:毒性研究中的全身性暴露量的评估 S3B: Pharmacokinetics: Guidance for...
S2B:Genotoxicity:AStandardBatteryforGenotoxicityTestingforPharmaceuticals 基因毒性:药物基因毒性检验的标准 S3A:NoteforGuidanceonToxicokinetics:TheAssessmentofSystemicExposureinToxicityStudies 毒物代谢动力学指南的注释:毒性研究中的全身性暴露量的评估 S3B:Pharmacokinetics:GuidanceforRepeatedDoseTissueDistributionStudies 药物...
Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals 受法规管辖的药物基因毒性检验的特定方面的指南 S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals 基因毒性:药物基因毒性检验的标准 S3A: Note for Guidance on Toxicokinetics: The Assessment of System...
最新ICH指导原则讲解.ppt,ICH Guidelines 王震 2015-02-01 ICH Guidelines 说明 ICH的论题主要分为四类,因此ICH根据论题的类别不同而进行相应的编码分类: “Q”类论题:Q代表QUALITY,指那些与化工和医药,质量保证方面的相关的论题。 “S”类论题:S代表SAFETY,指那些与