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小鼠淋巴瘤细胞tk基因突变试验的结果判定

Result evaluation of thymidine kinase gene mutation assay in mouse lymphoma cells
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摘要 小鼠淋巴瘤细胞tk基因突变试验(MLA)是遗传毒性试验标准组合推荐方法之一,在药物非临床安全性评价及其他领域被广泛使用。本文以遗传毒性试验国际工作会议(IWGT)进行MLA国际验证的相关内容为依据,介绍MLA有关背景数据和结果判定的新标准,供国内同行参考,并建议在试验研究中采纳。 Thymidine kinase gene mutation assay in mouse lymphoma cells is a recommended method of genotoxicity as an evaluation standard battery.It has been applied widely in non-clinical safety research in drug evaluation and other areas.Based upon the contents of International Workshops on Genotoxicity Testing（IWGT） international validation of MLA test,the new criterion of its background data ranges and outcome decision were illuminated in this paper in order to give suggestions to domestic counterparts.
作者 王欣 王雪 张旻 胡燕平 宋捷 李波
机构地区 中国药品生物制品检定所国家药物安全评价监测中心
出处 《中国新药杂志》 CAS CSCD 北大核心 2010年第16期1399-1401,共3页 Chinese Journal of New Drugs
基金 重大新药创制科技重大专项(2008ZX09305-002)
关键词 小鼠淋巴瘤细胞tk基因突变试验 遗传毒性试验 药物安全性评价 遗传毒性试验国际工作会议 mouse lymphoma assay（MLA） genotoxicity test drug safety evaluation International Workshops on Genotoxicity Testing（IWGT）
分类号 R944 [医药卫生—药剂学]
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参考文献11

  • 1ICH S2 ( R1 ). Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use (current step2 version)[S/OL]. (2008 -03 -06). http://www. ich. org/LOB/media/MEDIA4474. pdf.
  • 2FDA. Guidelines redbook 2000: IV. C. 1. c mouse lymphoma thymidine kinase gene mutation assay[ S ]. 2006.
  • 3OECD. Guidelines for the testing of chemicals 476 : in vitro mammalian cell gene mutation test[ S]. 1997.
  • 4ISO 10993-3. Biological evaluation of medical devices-Part 3: Tests for genotoxieity, carcinogenicity and reproductive toxicity [S]. 2003.
  • 5国家食品药晶监督管理局.药物遗传毒性研究技术指导原则[S].2007.
  • 6GB/T16886.3-2008/ISO 10993-3.医疗器械生物学评价-第3部分:遗传毒性、致癌性和生殖毒性试验[S].2003.
  • 7MOORE MM, HONMA M, CLEMENTS J, et al. Mouse lymphoma thymidine kinase gene mutation assay: international workshop on genotoxicity tests workgroup report-plymouth, UK 2002 [J]. Mutat Res, 2003, 540(2) : 127 - 140.
  • 8MOORE MM, HONMA M, CLEMENTS J, et al. Mouse lymphoma thymidine kinase gene mutation assay: follow-up meeting of the international workshop on genotoxicity testing-aberdeen, scotland, 2003-assay acceptance criteria, positive controls, and data evaluation[ J]. Environ Mol Mutagen, 2006, 47 ( 1 ) : 1 - 5.
  • 9MOORE MM, HONMA M, CLEMENTS J, et al. Mouse lymphoma thymidine kinase gene mutation assay: meeting of the international workshop on genotoxicity testing, San Francisco, 2005, recommendations for 24-h treatment [ J ]. Mutat Res, 2007, 627 (1) : 36 -40.
  • 10MOORE MM, HONMA M, CLEMENTS J, et al. Mouse lymphoma thymidine kinase gene mutation assay: follow-up international workgroup on genotoxicity test procedures, New Orleans, Louisiana, April 2000 [J]. Environ Mol Mutagen, 2002, 40 (4) : 292 - 299.

二级参考文献3

  • 1ICH S2A. Specific Aspects of Regulatory Genotoxidty Tests for Pharmaceuticals [EB/OL] . 1995. http: //www. ich.org/LOB/ media/MEDIA493.pdf.
  • 2ICH S2B. A Standard Battery for Genotoxicity Testing of Pharmaceuticals [EB/OL] . 1997. http: //www. ich. org/ LOB/media/MEDIA494. pdf.
  • 3ICH S2 (R1) . Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use (Current Step 2 version) [EB/OL].2008. http: // www. ich. org/LOB/media/MEDIA4474, pdf.

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中国新药杂志
2010年 第16期

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