International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic ri(国际协调人用药品注册技术要求会议 (ICH) 指南 M7 关于评估和控制药品中的 DNA 反应性（诱变）杂质以限制潜在致癌风险)