ICHM7[step4]基因毒性杂质评估和控制◆中英.docVIP

WORD格式整理 专业知识分享 ASSESSMENT AND?CONTROL OF?DNA REACTIVE(MUTAGENIC) IMPURITIES IN?PHARMACEUTICALS TOLIMIT?POTENTIAL?CARCINOGENIC?RISK 为限制潜在致癌风险而对药物中DNA活性（诱变性）杂质进行的评估和控制 M7 Current?Step 4?version dated 23 June 2014 This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Jap