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ICH遗传毒性研究指导原则修订的最新进展 被引量：3

ICH Guideline on Genotoxicity:Latest Progress in Revision
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摘要 目的介绍ICH关于遗传毒性研究的指导原则修订的最新进展。方法介绍ICH遗传毒性研究指导原则修订的背景、修订的经过及要点。结果修订的指导原则在标准试验组合、体内试验和体外试验的选择、结果分析及评价等方面做了若干修订,提出了新的要求。结论修订后的指导原则ICH S2更具科学性和可操作性。 Objective To introduce the latest progress of ICH S2 revisions. Methods The background, process and important points of the revision were introduced in this article. Results The standard battery of genotoxicity test, choice of in vitro and in vivo assays, interpretation and evaluation of results in ICH S2 had been revised. Conclusions ICH S2 revision is more scientific and practicable.
作者 王雪 宋捷 张旻 胡燕平 王欣 李波 王军志
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 《中国药事》 CAS 2009年第5期491-494,共4页 Chinese Pharmaceutical Affairs
关键词 ICH指导原则 遗传毒性 标准试验组合 体外哺乳动物细胞试验 3R ICH guideline genotoxicity standard battery for genotoxicity testing in vitro mammalian cells assay 3R
分类号 R951.01 [医药卫生—药学]
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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.

同被引文献14

  • 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.

引证文献3

二级引证文献9

中国药事
2009年 第5期

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