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

药品试验数据保护制度中的新化学实体界定问题研究——基于美国Actavis公司诉FDA Vyvanse案的实证分析 被引量：3

Definition of new chemical entity in pharmaceutical data protection regime—an empirical analysis of Actavis vs.FDA on Vyvanse
原文传递
导出
摘要 本文旨在以美国Actavis公司与美国食品和药物管理局(FDA)就创新药物二甲磺酸赖右旋安非他明(商品名:Vyvanse)的新化学实体(NCE)界定和数据保护案例为研究样本,采用案例分析方法,详细阐述关于NCE界定过程中的程序和实体问题,以期为我国NCE的界定以及药品数据保护法规完善提供政策借鉴。 Based on the study on new chemical entity （NCE） definition and data protection in the case of an innovative drug--lisdexamfetamine dimesylate （trade name： Vyvanse） by Actavis Inc. vs. United States Food and Drug Administration, this paper employed case analysis method and elaborated on the issue of procedures and entities during NCE definition, hoping improvement of pharmaceutical data protection regime in to provide policy reference for the NCE definition and China.
作者 丁锦希 王颖玮 贺晓雪 孟立立
机构地区 中国药科大学医药知识产权研究所
出处 《中国新药与临床杂志》 CAS CSCD 北大核心 2012年第11期652-657,共6页 Chinese Journal of New Drugs and Clinical Remedies
基金 国家社会科学基金项目(10CFX055) 中央高校基本科研业务费专项基金资助项目(JKY2011104)
关键词 药品数据保护 新化学实体 实证研究 pharmaceutical data protection new chemical entity empirical research
分类号 R951 [医药卫生—药学]
  • 相关文献

参考文献10

  • 1吉萍.药物临床试验在中国开展之新变化[J].中国新药与临床杂志,2011,30(12):956-960. 被引量：8
  • 2PhRMA. Pharmaceutical Industry Profile 2007 [EB/OL]. Pharmaceutical Industry Profile 2007. (2007-12-10)[2012-06- 13]. http://www.google.com/url?sa =t&rct =j&q =&esrc =s&source = web&cd =l&ved =0CCkQFjAA&url =http% 3A% 2F% 2Ffaculty. fuqua,duke.edu% 2F wil/m% 2FC/asses% 2FPharma_BG% 2FPHRMA% 2FPHRMA_Industry_Profile_2007. pdf&ei = V7dk ULTONaPjiAKdyIHABQ&usg =AFQjCNE6TxTWLmIDyePZ OEd 4d-nAAfUbuQ&sig2,=jdbWgigu - MjxX- 6i9LvUeA.
  • 3PhRMA. Pharmaceutical Industry Profile 2011 [EB/OL]. Pharmaceutical Industry Profile 2011. (2012-03-14)[2012-06- 13]. http://www.phrma.org/sites/default/files/159/phrma_pmfil e _ 201 l_final.pdf.
  • 4SDI/Verispan. 2008 Top 200 branded drugs by retail dollars[EB/ OL]. (2009-06-16)[2010-12-13]. http://www.google.eom/ud? sa =t&rct =j&q =&esre =s&source =web&ed =l&ved = 0CCkQFjAA&url =http% 3A% 2F% 2Fwww.modemmedieine.eom% 2Fmodemmedicine% 2FChains% 2B% 2526% 2BBusiness% 2F2008 - Top - 200 - branded - drugs - by - retail - dollars% 2FArtieleStandard% 2FArtiele% 2Fdetail% 2F597083&ei = 4qdkUPqwLKqTiALfklCIBw&usg=AFQjCNGHAY - EZPWALDD8 71 B_._SxPzy4pjw&sig2=HIbS 1 rnglRLE 1 teM6pC8K0w.
  • 5SDI/Verispan. 2008 Top 200 branded drugs by total prescriptions [EB/OL]. (2009-06-16)[2010-12-13]. http://www.google.com/ url?sa =t&rct =j&q =&esre =s&source =web&ed =2&red =0CDAQFj AB&rl =http% 3A% 2F% 2Fdrugtopics.modemmedicine. corn% 2Fdrugtopics% 2Fdata% 2Farticlestandard% 2F% 2Fdrugtopics% 2F222009% 2F599844% 2Farticle.pdf&ei = d7BkUO - ZErHAiwKHm4GgDw&usg=AFQjCNExA8BeQvIuGpjJ5 pursWR8 L3eRw&sig2=Mv3hYDbTiUnsZhcI9ubxVw.
  • 6SDI/Verispan. 2009 Top 200 branded drugs by retail dollars[EB/ OL]. (2010-06-15)[2010-12-13]. http://www.google.eom/url? =t&rct =j&q =&esrc =s&source =web&cd =l&ved = 0CCkQFjAA&url =http% 3A% 2F% 2Fwww.modemmedicine.com% 2Fmodemmedicine% 2FClinical% 2BNews% 2F2009 - Top - 200 - branded - drugs - by - retail - dollars% 2FArtieleStandard% 2FArticle% 2Fdetail% 2F674961&ei =tbBkUKrCNub5igKRq4 GgAw&usg =AFQjCNG8YI3TnsOPTJ8 - tmbeEKxwS5Blpg&sig2 = 6kIXlb 10V 1 bqCloSUOy 1Fg.
  • 7SDl/Verispan. 2009 Top 200 branded drugs by total prescriptions [EB/OL]. (2010-06-15)[2010-12-13]. http://www.google.eom/ url?sa =t&rct =j&q =&esre =s&source =web&ed =l&ved =0CCYQFjAA&url=http% 3A% 2F% 2Fwww.modemmedieine.com% 2Fmodemmedicine% 2FClinical% 2BNews% 2F2009 - Top - 200 - branded - drugs - by - total - prescriptions% 2FArticleStandard% 2FArticle% 2Fdetail% 2F674969&ei =IbFkUOG1C6nOiwLz2I HQDg&usg =AFQjCNESvYoP413b5Sgdhs - cQ3gWqlfixQ&sig2 = Ph205rMfgqP7zlxGkWbbAg.
  • 8SDI/Verispan. 2010 Top 200 branded drugs by total retail dollars [EB/OL]. (2011- 06- 01) [2012- 04- 07]. http://drugtopics. modemmedicine.com/drugtopics/data/articlestandard//drugtopics/ 252011/727252/article.pdf.
  • 9SDI/Verispan. 2010 Top 200 branded drugs by total prescriptions [EB/OL]. (2011- 06- 01) [2012- 04- 07]. http://drugtopics. modernmedicine.com/drugtopics/data/articlestandard//drugtopics/ 252011/727256/article.pdf.
  • 10丁锦希,孟立立,罗茜玮.日本创新药物研发激励政策及对我国的启示——基于依达拉奉研发的实证分析[J].中国新药与临床杂志,2011,30(11):839-847. 被引量：5

二级参考文献51

共引文献11

同被引文献53

  • 1崔怡.药品利益论衡——2005药品数据保护国际研讨会综述[J].WTO经济导刊,2005(4):46-50. 被引量：1
  • 2European Medicines Agency (EMA).Concept Paper on the Revision of the Guideline on Similar Biological Medicinal Product[Z].London: EMA, 2011.
  • 3World Health Organization (WHO).Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs)[R].Geneva: WHO, 2009.
  • 4Health Canada.Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs)[R].Ottawa: Health Canada, 2010.
  • 5Kaur Chugh P, Roy V.Biosimilars: Current Scientific and Regulatory Considerations[J].Current clinical pharmacology, 2014, 9(1): 53-63.
  • 6Jha D, Mishra R K, Pandey R.Biosimilars: Current regulatory perspective and challenges[J].Journal of pharmacy & bioallied sciences, 2013, 5(1): 80.
  • 7Ministry of Health, Labour and Welfare (MHLW).Guidelines for the Quality, Safety and Efficacy Assurance of Follow-On Biologics[R].Tokyo: MHLW, 2009.
  • 8Weise M, Bielsky M C, De Smet K, et al.Biosimilars [mdash] why terminology matters[J].Nature biotechnology, 2011, 29(8): 690-693.
  • 9Carey K.Biosimilars encircle Rituxan, US debates innovator exclusivity[J].Nature biotechnology, 2011, 29(3): 177-178.
  • 10Schellekens H, Ryff J C.\'Biogenerics’: the off-patent biotech products[J].Trends in pharmacological sciences, 2002, 23(3): 119-121.

引证文献3

二级引证文献8

中国新药与临床杂志
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