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

美国儿科用药数据保护制度及其对儿童用药安全的影响分析 被引量：7

原文传递
导出
摘要 目的为我国完善儿科用药相关政策提供参考。方法采用案例分析法评价美国儿科用药数据保护政策对儿童用药安全的影响。结果与结论美国儿科用药数据保护政策在一定程度上激励了儿童临床研究的开展,提高了儿童用药的安全性,我国可以借鉴美国的成功经验,建立儿科用药数据保护制度,提高我国儿童健康水平。
作者 丁锦希 邓媚 白庚亮
机构地区 中国药科大学医药知识产权研究所
出处 《中国药学杂志》 CAS CSCD 北大核心 2012年第10期749-752,共4页 Chinese Pharmaceutical Journal
基金 国家社会科学基金项目名称<创新药物研发科技投入与激励法律制度研究>(10CFX055)
关键词 儿科用药 数据保护 儿童用药安全
分类号 R95 [医药卫生—药学]
  • 相关文献

参考文献16

  • 1李智平.重视儿科的药物临床试验[J].儿科药学杂志,2009,15(4):4-6. 被引量：11
  • 2罗纯,李野,杨莉.美国的儿科药品政策研究及对我国的启示[J].中国药房,2009,20(28):2168-2170. 被引量：5
  • 3FDA. Implementation of the Pediatric Exclusivity Provisions [EB/OL]. http: //www. fda. gov /News Events /Testimony/ ucm115220, htm.
  • 4FDA. Guidance for Industry-Qualifying for Pediatric Exclusivity Under SectionS05A of the Federal Food, Drug and Cosmetic Act [EB/OL]. http://www, fda. gov/cber/gdlns/pedexc, htm.
  • 5杨莉,罗纯,陈晶.儿科独占制度研究(一)[J].中国新药杂志,2009,18(8):677-680. 被引量：7
  • 6SMITH P B, BENJAMIN JR D K, MURPHY M D, et al. Safety monitoring of drugs receiving pediatric marketing exclusivity [ J ]. Pediatrics, 2008,122 ( 3 ) : 628-633.
  • 7ALAN M. SHAPIRO M D. Implementation of the Best Pharma- ceuticals for Children Act: the FDA Pediatric Post-Marketing Safety Review Experience [EB/OL]. http://www, fda. gov/ downloads/AboutFDA/CentersOffices/CDER/ucm 120016. pdf.
  • 8ZHANG H F LI P P WANG Y et al.Large sample survey and a- nalysis of the application of the pediatric antimicrobial drug .中国药学杂志,2007,42(16):1268-1268,1270.
  • 9LIANGYP ZHANGXP ZHAOQ.Analysis of181cases of the use of pediatric lower respiratory tract antibacterial drug survey .中国药学杂志,2009,44(1):70-72.
  • 10XIEJP WUYH.The use of pediatric inpatient antimicrobial druginthehospital.中国药学杂志,2006,41(2):157-158.

二级参考文献42

  • 1HOREN B, MONTASTRUC JL, LAPEYRE-MESTREM,et al. Adverse drug reactions and off-label drug use in pediatric patients [ J ]. Br J Clin Pharmacol,2002,54 (6) : 665 - 670.
  • 2Guidance for Industry Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act[EB/ OL]. [2007 - 12 -08 ]. http://www. fda. gov/cder/guidance/ index. htm.
  • 3LEDERER SE, GRODIN M. Historical overview: pediatric experimentation, in children as research subjects [M]. US: Sci Ethics Law, 2003:3,4 - 18.
  • 4RYAN AE. Note, protecting the rights of pediatric research subjects in the international conference on harmonization of technical requirements for registration of pharmaceuticals for human use [M].US: 23 Fordham Int'l L. J.,2001:848, 852-853.
  • 5KARST KR. Pediatric testing of prescription drugs: the food and drug administration's carrot and stick for the pharmaceutical industry[J]. Br J Clin Pharmacol,2002 ,56 : 739 - 741.
  • 6Roberts R, Rodriguez W, Murphy D, et al. Pediatric drug labeling: improving the safety and efficacy of pediatric therapies[J ] .JAMA, 2003, 290(7) :905.
  • 7Mathis L. Growth and Development of Pediatric Drug Development at the FDA [EB/OL]. http://www.fda. gov/oc/opt/presentations/drugdevelopment .ppt. 2006- 06.2008- 07.
  • 8FDA. The Pediatric Exclusivity Provision [EB/OL]. http://www, fda .gov/cder/pediatric/reportcong01. pdf. 2001 - 01. 2008 - 07.
  • 9FDA. Food and Drug Administration Amendments Act of 2007[ EB/OL ] . http ://frwebgate. access, gpo. gov/cgi - bin/getdoc .cgi? dbname = 110_cong_public_ laws&docid = f:pub1085.110. 2007- 09. 2008- 07.
  • 10FDA.Best Pharmaceuticals for Children Act [EB/OL]. http ://www. fda. gov/opacom/laws/pharmkids/contents .html. 2002 - 01. 2008 - 07.

共引文献20

同被引文献98

  • 1宋儒亮.我国超说明书用药的法定界限[J].中国处方药,2010,9(11):10-11. 被引量：16
  • 2郑晶心（摘）.儿科用英国国家处方集出版[J].国外药讯,2006(2):4-4. 被引量：2
  • 3中华人民共和国国家统计局.2010年第六次全国人口普查主要数据公报(第1号)[EB/OL].http://www.stats.gov.cn/tjfx/jdfx/t20110428_402722253.htm,2011-04-28.
  • 4张虹,杜天信.《JCI标准》在医院药学服务中的应用[J].中国药房,2007,18(25):1946-1947. 被引量：35
  • 5陈铮.儿童用药产业呼唤系统的政策支持[N].中国医药报,2012-07-10(5).
  • 6吉翔.儿童药研发的挑战:品种少剂型缺信息不全[EB/OL].(2013-12-20)[2014一01-22].http://finance.ehi-nanews.com/jk/2013/12-20/5641542.shtml.
  • 7YAO L. FDA takes step to encourage pediatric drug studies[ EB/ OL]. (2013-08-16)[2014-01 -22]. http://blogs, fda. gov/fdavoice/index, php/tag/food-and -drug-administra-tion -safe- ty-and-innovation -act-fdasia/.
  • 8BENJAMIN D. A Message from the Lead Investigator[J]. PTN Post, 2012, 9(2) :1.
  • 9FDA. Food and Drug Administration Safety and Innovation Act [EB/OL]. (2012-07-09)[2014-01-17]. http://www. gpo. gov/fdsys/pkg/PLAW-I 12publ144/pdf/PLAW-I 12-publ144. pdf.
  • 10FDA. New pediatric labeling information database [ EB/OL]. (2013-09-30) [2013 -10-30]. http://www, aeeessdata. fda. gov/seripts/sda/sdNavigation, cfm? filter = &sortColumn = 1 a&sd = labelingdatabase&page = 1.

引证文献7

二级引证文献39

中国药学杂志
2012年 第10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