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浅析药物的基因毒问题(5)

发表日期:2020-09-02 15:02 | 来源 :原创整理 | 点击数: 次 收听:
3. ICH.S2(R1):Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use. 2011

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。

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