期刊文献+

创新性化学药品在中国的申报状况研究 被引量:4

Research in Profile of Chemical Investigational New Drug Application in China
下载PDF
导出
摘要 通过对2005~2008年期间在我国申报的创新性化学药品的申请情况进行系统性分析,明确目前我国创新性药品研发和申报的现状。研究结果表明,创新性药品的申请数量近年来基本稳定,总体上国产申请和进口申请数量相近,申报的适应证领域比较集中,趋势与国际情况相似。 Through the systematical analysis in chemical investigational new drug (IND) applications from 2005 to 2008, the current situation of IND applications is confirmed. The results show that the number of applications keeps stable in recent years and that of imported and local applications is almost the same. The indications of those applications are relatively concentrated and the tendency is similar to that in the international reports.
出处 《食品与药品》 CAS 2009年第3期1-3,共3页 Food and Drug
关键词 创新性药品 审评 申报 investigational new drug evaluation application
  • 相关文献

参考文献12

  • 1Gassmann O, Reepmeyer G. Organizing pharmaceutical innovation: From science-based knowledge creators to drugoriented knowledge brokers[J]. Creat Innov Manag, 2005, 14(3): 233-245.
  • 2Hunt C A, Guzy S, Weiner D L. A forecasting approach to accelerate drug development[J]. Stat Med, 1998, 17(15-16): 1725-1740.
  • 3Rooney K F, Snoeck E, Watson P H. Modelling and simulation in clinical drug development[J]. Drug Disc Today, 2001, 6(15): 802-806.
  • 4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.
  • 5Foreign 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
  • 6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.
  • 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1

同被引文献43

  • 1吴泰相,李幼平,刘关键,李静,钟紫红,贾万年.临床试验注册制度与循证医学[J].中国循证医学杂志,2007,7(4):239-243. 被引量:21
  • 2DIMASIJA,HANSEN RW,GRABOWSKI HG. The price ofinnoration: new estimates of drug development costs [ J ]. J Health Econ,2003,22(2) :151 - 185.
  • 3Lilly's market prospects hang on new drug offerings [ JB/OL].[ 2009 - 06 - 04 ]. http ://news. medill, northwestern, edu/chicago/news, aspx? id=133215.
  • 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.
  • 10ROBERT 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.

引证文献4

二级引证文献40

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