基础导论药品中的遗传毒性杂质法规和分析23目录术语表........................................................................................................................................................4前言........................................................................................................................................................51.引言....................................................................................................................................................7药品中的杂质.......................................................................................................................................7本基础导论的内容...............................................................................................................................7资源.......................................................................................................................................................82.法规和指南...................................................................................................................................10ICH杂质方法——指南和分类........................................................................................................10PhRMA意见书...................................................................................................................................11EMA指南...........................................................................................................................................13FDA指南草案.....................................................................................................................................16ICHM7展望.......................................................................................................................................17遵照ICHS2(R1)进行遗传毒性试验...............................................................................................17实验室合规要求.....................................
