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

已上市2型糖尿病治疗药物的生殖毒性 被引量：2

Reproductive and developmental toxicity of the marketed anti-diabetic agents for type 2 diabetic mellitus
原文传递
导出
摘要 本文通过分析FDA等药品监管机构公开的药品说明书和评价报告等信息,总结具有代表性的已上市抗2型糖尿病药物的生殖毒性信息和安全性范围,为2型糖尿病药物的非临床安全性评价和临床生殖毒性风险控制措施的制订提供参考。 The aim of this review is to provide reference information for the non-clinical safety evaluation and reproductive toxicity risk management in clinical tirals for anti-diabetic agents.The reproductive and developmental toxicity information as well as the safety ranges of the representative anti-diabetic agents for type 2 diabetes mellitus on the market were summarized based on the labeling and review documents obtained from the official website of the US Food and Drug Administration and other regulatory agencies.
作者 余珊珊 尹华静 周恒 王庆利 胡晓敏
机构地区 国家食品药品监督管理总局药品审评中心
出处 《中国新药杂志》 CAS CSCD 北大核心 2017年第23期2772-2779,共8页 Chinese Journal of New Drugs
关键词 2型糖尿病治疗药物 生殖毒性 安全范围 风险控制 anti-diabetic agents for type 2 diabetes mellitus （T2DM） reproductive and developmentaltoxicity safety range risk management
分类号 R95 [医药卫生—药学]
  • 相关文献

参考文献4

二级参考文献70

  • 1Parker JC. Troglitazone: the discovery and development of a novel therapy for the treatment of Type 2 diabetes mellitus[J ]. Adv Drug Deli Rev ,2002,54(9):1173 - 1197.
  • 2Chaudhry MU, Simmons DL. Case of month. Hepatic and renal failure in a patient taking troglitazone and metformin[J] J Ark Med Soc ,2001,98(1): 16 - 19.
  • 3Scheen AJ. Thiazolidinediones and liver toxicity [ J ]. Diabetes Metab ,2001,27(3) :305 - 313.
  • 4Wang K, Shindoh H, Inoue T, Horii I. Advantages of in vitro cytotoxicity testing by using primary rat hepatocytes in comparison with established cell line [ J ]. J Toxicol Sci, 2002, 27 ( 1 ):229 - 237.
  • 5Ishiyama M, Tominaga H, Shiga M, et al. Novel cell proliferation and cytotoxicity assays using a tetrazoloim salt that produces a water-soluble formazan dye [J ]. In Vitro Toxicol, 1995,8 (2):187- 190.
  • 6Cathcart R, Schwiers E, Ames BN. Detection of picomole levels of hydroperoxides using a fluorescent dichlorofluorescien assay[J]. Analytical Biochem, 1983,134(1): 111 - 116.
  • 7Osseni RA, Rat P, Bogdan A, et al. Ciracadian rhythms of glutathione and mitochondrial activity in human hepatic cell line[A]. Toutou Y. Influence of melatonin [ M]. Biological Clocks:Mechanisms and Application. Ist ed. Armsterdam: Elsevier,1998.111 - 114.
  • 8Peski AV, Winterbourn CC. A microtiter plate assay for superoxide dismutase using a water-soluble tetrazolium salt (WST-1)[J]. Clin Chim Acta ,2000,293(3):157- 166.
  • 9Shishido S, Koga H, Harada M, et al. Hydrogen peroxide overproduction in megamitochondria of troglitazone-treated human hepatocytes[ J ]. Hepatology, 2003,37 ( 1 ): 136 - 147.
  • 10Bae MA, Song BJ. Critical role of c-Jun N-terminal protein kinase activation in troglitazone-induced apoptosis of human HepG2 hepatoma cells[ J ]. Mol Pharmacol, 2003,63 (2): 401 - 408.

共引文献35

同被引文献13

引证文献2

二级引证文献3

中国新药杂志
2017年 第23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