ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the...
Multidisciplinary Guidelines多学科兼容的指南 M1: Medical Terminology 医学术语 M2: Electronic Standards for Transmission of Regulatory Information (ESTRI) 药政信息传递之电子标准 M3: Timing of Pre-clinical Studies in Relation to Clinical Trials (See Safety Topics) 有关临床试验的临床前研究的时间安排 M4:...
2、新药研发&临床高端“宝藏”交流群 3、新药实验室&生物样本分析“宝藏”交流群 4、药物创新项目lincesin in/out 5、创新药研发申报流程/相关费用预算 (药物CMC、动物安评、IND注册、医学方案、临床运营、数据管理&统计分析、药物警戒、医学监察、实验室/生物样本分析...
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 Q3A和Q3B的...