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促进我国创新药研发关键技术要素的探讨 被引量:6

Key factors in promoting the research and development of investigational new drugs in China
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摘要 文中通过对近年来国内化学药品研发申报的现状进行分析,结果显示我国目前是以仿制药申报为主,并逐步转向仿创结合的模式。结合在创新药研发中制药企业存在的不足,文中提出将建立创新药整体研发思路、构建适应创新研发学科需要的团队以及提高沟通交流能力作为提高我国创新药研发的关键要素。 Through analysis in chemical drug submission in recent years,the current situation is confirmed.The results show that primary submissions are generic drugs,and the submission involving investigational new drug (IND) is increasing.Based on the shortcoming in IND research and development of Chinese industries,some key factors need to improve,including establishing the systematical research and development strategy,organizing the whole team,improving the communication,and so on.
出处 《中国新药杂志》 CAS CSCD 北大核心 2010年第7期558-560,共3页 Chinese Journal of New Drugs
关键词 创新药 申报 关键要素 研发 investigational new drug submission key factor research and development
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参考文献5

  • 1杨志敏,史继峰,温宝书,杨建红,冯毅.创新性化学药品在中国的申报状况研究[J].食品与药品,2009,11(3):1-3. 被引量:4
  • 2ROBERT WP. GORDON RJ. A comparison of product development, lifecycle, and approval pathways:brand vs generic products [EB/OL]. (2005 - 05 - 01 ). http://secure, pharmacytimes. com/lessons/200205 - 01. asp.
  • 3JOSEF HR, WILLAM DT. Work group report on:the drug development pipeline [ EB/OL ].(2005 - 03 - 01 ). http ://www. massinsight, com/docs/DrugDev, pdf.
  • 4TAN DS, THOMAS GV,GARRETT MD,et al. Biomarker-driven early clinical trials in oncology: a paradigm shift in drug development[ J ]. Cancer J, 2009,15 (5) :406 - 420.
  • 5MILLER R, EWY W,CORRIGAN BW,et al. How modeling and simulation have enhanced decision making in new drug development[ J]. J Pharmacokinet Pharmacodyn, 2005,32(2) :185 - 197.

二级参考文献12

  • 1药品注册管理办法[z].国家食品药品监督管理局令第28号,2007.
  • 2Gassmann O, Reepmeyer G. Organizing pharmaceutical innovation: From science-based knowledge creators to drugoriented knowledge brokers[J]. Creat Innov Manag, 2005, 14(3): 233-245.
  • 3Hunt C A, Guzy S, Weiner D L. A forecasting approach to accelerate drug development[J]. Stat Med, 1998, 17(15-16): 1725-1740.
  • 4Rooney K F, Snoeck E, Watson P H. Modelling and simulation in clinical drug development[J]. Drug Disc Today, 2001, 6(15): 802-806.
  • 5药品审评中心创新性药品技术审评工作程序(试行)[Z].http://www.cde.org.cn.
  • 6Foreign clinical studies not conducted under an IND(21 C. F.R.312.120)[Z]. FDA regulations relating to good clinical practice and clinical trials, http://www.fda.gov/oc/gcp/regulations.html
  • 7Neufeld G, Cohen T, Gengrinovitch S, et al. Vascular endothelial growth factor (VEGF) and its receptors[J]. FASEB J, 1999, 13(1): 9-22.
  • 8Dutta P R, Maity A. Celhrlar responses to EGFR inhibitors and their relevance to cancer therapy [J]. Cancer Lett, 2007, 254(2): 165-177.
  • 9Guan Y, Breyer M. Peroxisome proliferators activated receptors(PPARs): Novel therapeutic targets in renal disease [J]. Kidney Int, 2001, 60: 14-30.
  • 10McCormack J G, Freyse E J, Berg S, et al. Effects of the short-acting dipeptidyl peptidase IV inhibitor PSN9301 and metformin alone and in combination on glucose tolerance and body weight in the fa/fa Zucer rat, and in a polygenetic rat model of diabetes[J]. Diabetologia, 2005, 48(S1): A287.

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