期刊文献+
任意字段
题名或关键词
题名
关键词
文摘
作者
第一作者
机构
刊名
分类号
参考文献
作者简介
基金资助
栏目信息

体内Pig-a基因突变试验方法的开发 被引量：1

Progress of in vivo Pig-a gene mutation assay
原文传递
导出
摘要 体内基因突变是遗传毒理试验中非常重要的检测终点。国际人用药物注册技术协调会议(ICH)新版遗传毒性指导原则的出台,对体内遗传毒性检测方法的发展提出了更高的要求。新的检测体细胞突变的体内实验方法即磷脂酰肌醇聚糖A(Pig-a)基因突变试验,有望成为一项新药遗传毒性评价的标准试验。本文简要综述Pig-a体内基因突变试验的特点及其在新品种开发遗传毒性检测中的应用。 In vivo gene mutation is a key genetic toxicology endpoint.Recently,the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use（ICH） published genotoxic-guideline,more emphasis will be placed on the results of in vivo genotoxicity testing assays.In the recent years,a new in vivo genotoxicity tests have been developed,especially for the in vivo Pig-a gene mutation assay which is under international validation and potential to be a tool for regulatory safety assessment.This paper mainly reviews characteristics of the in vivo Pig-a gene mutation testing method and its application in the genotoxicity detection of new products.
作者 张铭 周长慧 王庆利 常艳
机构地区 中国医药工业研究总院国家上海新药安全评价研究中心 国家食品药品监督管理局药品审评中心
出处 《世界临床药物》 CAS 2012年第11期684-687,共4页 World Clinical Drug
基金 国家"十二五"重大专项基金资助项目(2012ZX09505-001-003)
关键词 磷脂酰肌醇聚糖A基因 遗传毒性 药物安全性 Pig-a gene genotoxicity drug safety
分类号 R394.6 [医药卫生—医学遗传学] R991 [医药卫生—毒理学]
  • 相关文献

参考文献22

  • 1ICH. Guidance on genotoxicity testing and data interpretationfor pharmaceuticals intended for human use [EB/OL].[2011-11-09] .http://www.ich.org/products/guidelines/safety/article/safety-guidelines.html.
  • 2Bryce SM, Bemis JC, Dertinger SD. In vivo mutation assaybased on the endogenous Pig-a locus [J]. Environ MolMutagen, 2008,49 (4) :256-264.
  • 3Kawagoe K,Takeda J, Endo Y, et al. Molecular cloningof murine Pig-a9 a gene for GPI-anchor biosynthesis, anddemonstration of interspecies conservation of its structure,function, and genetic locus [J]. Genomics, 1994,23 (2) :566-574.
  • 4Araten DJ, Nafa K,Pakdeesuwan K, et al. Clonalpopulations of hematopoietic cells with paroxysmal nocturnalhemoglobinuria genotype and phenotype are present innormal individuals [J]. Proc Natl Acad Sci USA , 1999,96(9):5209-5214.
  • 5Miura D, Dobrovolsky VN, Mittelstaedt RA, et al.Development of an in vivo gene mutation assay using theendogenous Pig-a gene: II. selection of Pig-a mutant ratspleen T-cells with proaerolysin and sequencing Pig-acDNA from the mutants [J], Environ Mol Mutagen, 2008,49(8):622-630.
  • 6Miura D, Dobrovolsky VN, Kasahara Y,et al. Developmentof an in vivo gene mutation assay using the endogenousPig-a gene: I. flow cytometric detection of CD59- negativeperipheral red blood cells and CD48-negative spleen T cellsfrom the rat [J]. Environ Mol Mutagen, 2008, 49(8) :614-621.
  • 7Dertinger SD, Phonethepswath S, Weller P,et al. InternationalPig-a gene mutation assay trial: evaluation of transferabilityacrossl4 laboratories [J]. Environ Mol Mutagen, 2011,52 (9) :690-698.
  • 8Kinoshita T, Fujita M, Maeda Y. Biosynthesis, remodelingand functions of mammalian GPI-anchored proteins: recentprogress [J]. J Biochem, 2008,144 (3) :287-294.
  • 9Brodsky RA, Hu R. Pig-a mutations in paroxysmal nocturnalhemoglobinuria and in normal hematopoiesis [J]. LeukLymphoma, 2006,47 (7) :1215-1221.
  • 10Takeda J,Miyata T, Kawagoe K, et al. Deficiency of theGPI anchor caused by somatic mutation of Pig-a gene inparoxysmal nocturnal hemoglobinuria [J]. Cell, 1993,73 (4):703-711.

同被引文献48

  • 1Bryce SM,Bemis JC,Dertinger SD.In vivo mutation assay basedon the endogenous Pig-a locus[J].Environ Mol Mutagen,2008,49(4):256-264.
  • 2Dobrovolsky VN,Miura D,Heflich RH,et al.The in vivo Pig-agene mutation assay,a potential tool for regulatory safetyassessment[J].Environ Mol Mutagen,2010,51(8/9):825-835.
  • 3Krewski D,Acosta D Jr,Andersen M,et al.Toxicity testing inthe 21st century ; a vision and a strategy[J].J Toxicol EnvironHealth B Crit Rev,2010,13(24):51-138.
  • 4Food and Drug Administration,HHS.International Conference onHarmonization ; guidance on S2(Rl)Genotoxicity Testing andData Interpretation for Pharmaceuticals intended for Human Use;availability.Notice[J].Fed Regist,2012,77(110):33748-33749.
  • 5Kawagoe K,Takeda J,Endo Y,et al.Molecular cloning ofmurine Pig-a,a gene for GPI-anchor biosynthesis,anddemonstration of interspecies conservation of its structure,function,and genetic locus[J].Genomics,1994,23(3):566-574.
  • 6Takahashi M,Takeda J,Hirose S,et al.Deficient biosynthesis of N-actylglucosaminyl-phosphatidylinositol,the first intermediate ofglycosyl phosphatidylinositol anchor biosynthesis,in cell linesestablished from patients with paroxysmal nocturnal hemoglobinuria[J].J Exp Med,1993,177(2):517-512.
  • 7Norris J,Hall S,Ware RE,et al.Glycosyl-phosphatidylinositolanchor synthesis in paroxysmal nocturnal hemoglobinuria:Partial orcomplete defect in an early step[J].Blood,1994,83(3):816-821.
  • 8Miura D,Dobrovolsky VN,Mittelstaedt RA,et al.Developmentof an in vivo gene mutation assay using the endogenous Pig-agene:II.Selection of Pig-a mutant rat spleen T-cells withproaerolysin and sequencing Pig-a cDNA from the mutants[J].Environ Mol Mutagen,2008,49(8):622-630.
  • 9Phonethepswath S,Bryce SM,Bemis JC,et al.Erythrocyte-based Pig-a gene mutation assay:Demonstration of crossspeciespotential[J].Mutat Res,2008,657(2):122-126.
  • 10Peruzzi B,Araten DJ,Notaro R,et al.The use of PIG-A as asentinel gene for the study of the somatic mutation rate and ofmutagenic agents in vivo[J].Mutat Res,2010,705(1):3-10.

引证文献1

世界临床药物
2012年 第11期

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部