4. ICH.M3 (R2): Non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals. 2009
5. FDA. Guidance for industry and review staff: Recommended approaches to integration of genetic toxicology study results. 2006
6. OECD. Guideline for testing of chemicals No.471:Bacterial reverse mutation test.1997
7. OECD. Guideline for testing of chemicals No.473:InVitro mammalian chromosomal aberration test. 2016
8. OECD. Guideline for testing of chemicals No. 488:Transgenicrodent somatic and germ cell gene mutation assays. 2013
9. OECD. Guideline for testing of chemicals No. 489:Invivo mammalian alkaline comet assay. 2016
10. OECD. Guideline for testing of chemicals No. 490:Invitro mammalian cell gene mutation tests using the thymidine kinase gene. 2016
11. M7 评估和控制药物中 DNA 反应性(致突变)杂质以限制潜在的致癌风险.
12. M7(R1):评估和控制药物中DNA反应性(致突变)杂质以限制潜在致癌风险.
13. 遗传毒性杂质的警示结构.CNKI
14. http://samr.cfda.gov.cn/WS01/CL0087/226424.html
15. 书籍:《毒理学》-毒物的基础科学
原标题:浅谈:从药理&毒理&警示结构,理解药物的基因毒问题!
*声明:本文由入驻新浪医药新闻作者撰写,观点仅代表作者本人,不代表新浪医药新闻立场。