Lisa_S
回复了帖子 1类药基因毒警示结构杂质限度问题
331天前
不知道楼主要的1类新药现在是处于第几期研究,如果是属于IND I期临床申报,按照ICH M7指导原则,仅仅是有警示结构,而没有明确的致癌致突变数据,是不需要做进一步研究的,只需要当作普通杂质进行控制。An alternative approach to the strict use of an adjusted acceptable intake for any mutagenic impurity could be applied for Phase 1 clinical trials for dosing up to 14 days. For this approach, only impurities that are known mutagenic carcino