《M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk- Questions and Answers评估和控制药物中的DNA反应性(致突变)杂质以限制潜在致癌风险问答》中ICH回答了针对M7指南内容的26个问题(实际25个,问题9为空),翻译供业内参考。 问题1.注释1...
《M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk- Questions and Answers评估和控制药物中的DNA反应性(致突变)杂质以限制潜在致癌风险问答》中ICH回答了针对M7指南内容的26个问题(实际2...
#Questions 问 1.1 Note 1 provides general guidance on the relationship of ICH M7 with ICH Q3A and Q3B. The use of both “mutagenic potential” and “genotoxic potential” in Note 1 is confusing. Are these terms considered interchangeable? 注1给出了ICH M7与ICH...
Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk- Questions and Answers评估和控制药物中的DNA反应性(致突变)杂质以限制潜在致癌风险问答》、《M7(R2)Addendum: Application of the Principles of the ICH M7 Guidance to Calculation of Compound-Specific Acceptable Intakes(附录:ICH M7指导原则在计...
M7 Implementation Working Group ICH M7(R2) Guideline: ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK Questions and Answers M7(R2) Q&As Adopted on 24 May 2022 International Council for Harmonisation of Technical Requirements for ...
申请人应在申请中提供有关上游流程的信息,以证明拟议的起始材料的合理性,包括持续存在的杂质控制策略。 参考文献:Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and Answers
1215 Geneva, Switzerland Telephone: +41 (22) 710 74 80- admin@ich.org, http://www.ich.org M7 Implementation Working Group ICH M7 Guideline: ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK Questions and Answers Version: 29 Jun...
E2C(R2) InlPIementatiOn WOrking GrOUP QUeStIOnS &AnSWerS E2C(R2)实施丄作组问答部分 P: 段5 有 E2D E2D: POSt-APPrOVaI Safety Data Management: DefinitiOnS and StandardS for Expedited RePOrting E2D:上市后安全性数据的管理:快速报告 的定义和标准(中文版:征求意见稿) P 段5 有 E2E E2E: PharmaCOVig...
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:毒理动力学指导原则说明:毒性研究中系统性暴露的评价 1994.10.27 S3A Implementation Working Group Questions and Answers S3A实施工作...
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:毒理动力学指导原则说明:毒性研究中系统性暴露的评价 1994.10.27 S3A Implementation Working Group Questions and Answers S3A实施工作...