期刊文献+

创新性药物研发失败原因的探讨 被引量:3

Analysis of failures in the research and development of new drugs
原文传递
导出
摘要 通过对近年来在我国申报的创新性化学药品申请项目的审评情况以及不批准的原因进行系统分析,探求导致创新药研发失败的主要因素。分析结果显示,在11.4%不批准的创新性药品申请中,41%为临床定位不合理,29%为临床前安全性结果不支持临床方案。 We systemically analyzed the review results and failed reasons in applications for investigational new drugs. The aim of this paper was to analyze the main factors that led to failures in the research and development of new drugs. The results have shown that 11.4% applications were not approved by SFDA, in which 41% applications had no suitable and good clinical advantages, 29% applications had no adequate and good preclinical safety data to support the clinical trials.
作者 杨志敏 冯毅
出处 《中国新药杂志》 CAS CSCD 北大核心 2010年第1期17-19,共3页 Chinese Journal of New Drugs
关键词 创新性药物 研发 失败 investigational new drug research and development failure
  • 相关文献

参考文献9

  • 1DIMASIJA,HANSEN RW,GRABOWSKI HG. The price ofinnoration: new estimates of drug development costs [ J ]. J Health Econ,2003,22(2) :151 - 185.
  • 2Lilly's market prospects hang on new drug offerings [ JB/OL].[ 2009 - 06 - 04 ]. http ://news. medill, northwestern, edu/chicago/news, aspx? id=133215.
  • 3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
  • 4POLLOCK RW. A comparison of product development,tifecycle,and approval pathways: brand vs generic products [ EB/OL ]. [ 2005 - 05 - 01 ]. http ://secure. pharmacytimes, com/lessons/ 200205 - or. asp.
  • 5FDA. lnvestigational New Drug (IND) Application [ EB/OL ].[ 2009 -07 - 14 ]. http://www, fda. gov/Drugs/DevelopmentApprovalProcess/How DrugsareDevelopedand Approved/ApprovalApplications/lnvestigationalN ewDruglN DApplication/defauh. htm.
  • 6药品注册管理办法[S].国家食品药品监督管理局第28号,2007.
  • 7GASSMANN O. Organizing pharmaceutical innovation: from sci-ence-based knowledge creators to drug-oriented knowledge brokers. [ J ]. Creativity and Innovation Management, 2005,14 ( 3 ) : 233 - 245.
  • 8Rebuttals to PhRMA Responses to the Public Citizen Report. Rx R&D Myths:The Case Against The Drug Industry' s R&D 'Scare Card' [ EB/OL ]. http://www, citizen, org/congress/reform/drugindustr)/articles, cfm? ID =6514. 2001 -07023. http://www, citizen. org/congress/reform/drug_industry/articles, cfm? ID =6514.
  • 9KUHLMANN J. Alternative strategies in drug development:clinical pharmacological aspects[J]. Int J Clin Pharmacol Ther, 1999, 37(12) :575 -583.

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.

共引文献3

同被引文献29

引证文献3

二级引证文献8

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