| 文件名称： | ICH HARMONISED GUIDELINE ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK M7(R2) |
| 发布机构： | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH) | 发布日期： | 2023-04-03 |
| 简介/内容概述： | This guideline emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in final drug substance or product, taking into consideration the intended conditions of human use. |
