• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利：CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法，用中文像聊天一样搜索，搜遍4000万医学文献。AI智能推荐，让科研检索更轻松。

立即免费搜索

文件翻译

保留排版，准确专业，支持PDF/Word/PPT等文件格式，支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述，25分钟生成高质量综述，智能提取关键信息，辅助科研写作。

立即免费体验

Experience and further development with the Voluntary Harmonization Procedure for multinational clinical trials in the European Union.

作者信息

Krafft Hartmut, Bélorgey Chantal, Szalay Gudrun

出版信息

Nat Rev Drug Discov. 2012 May;11(5):419. doi: 10.1038/nrd3202-c2.

DOI:10.1038/nrd3202-c2
PMID:22679643
Abstract
摘要

相似文献

1
Experience and further development with the Voluntary Harmonization Procedure for multinational clinical trials in the European Union.
Nat Rev Drug Discov. 2012 May;11(5):419. doi: 10.1038/nrd3202-c2.
2
A sponsor's experience with the Voluntary Harmonization Procedure for clinical trial applications in the European Union.申办者在欧盟临床试验申请自愿协调程序方面的经验。
Nat Rev Drug Discov. 2011 May;10(5):393. doi: 10.1038/nrd3202-c1.
3
Stimulating pharmaceutical innovation in the EU.推动欧盟的制药创新。
Expert Rev Pharmacoecon Outcomes Res. 2011 Jun;11(3):235-9. doi: 10.1586/erp.11.19.
4
Three years of paediatric regulation in the European Union.欧盟三年儿科监管情况。
Eur J Clin Pharmacol. 2011 Mar;67(3):245-52. doi: 10.1007/s00228-011-0997-4. Epub 2011 Feb 1.
5
New regulatory rules for clinical trials in the United States and the European Union: key points and comparisons.美国和欧盟临床试验的新监管规则：要点与比较。
Arthritis Rheum. 2006 Dec;54(12):3735-40. doi: 10.1002/art.22215.
6
European union regulatory requirements.欧盟监管要求。
Front Neurol Neurosci. 2009;25:66-70. doi: 10.1159/000209477. Epub 2009 Mar 19.
7
Improvement of Pediatric Drug Development: Regulatory and Practical Frameworks.儿科药物研发的改进：监管与实践框架
Clin Ther. 2016 Mar;38(3):574-81. doi: 10.1016/j.clinthera.2016.01.012. Epub 2016 Feb 8.
8
European Medicines Agency policies for clinical trials leave women unprotected.欧洲药品管理局的临床试验政策使女性得不到保护。
J Epidemiol Community Health. 2006 Nov;60(11):911-3. doi: 10.1136/jech.2006.048769.
9
Similarity trials.相似性试验
Nat Biotechnol. 2011 Jan;29(1):1. doi: 10.1038/nbt.1760.
10
The Role of Drug Exposure in Clinical Development: To What Extent Is Pharmacokinetic Assessment Needed in a Drug Development Programme?药物暴露在临床开发中的作用：在药物开发计划中，药代动力学评估需要达到何种程度？
Clin Pharmacokinet. 2015 Oct;54(10):985-7. doi: 10.1007/s40262-015-0287-x.

引用本文的文献

1
Identifying obstacles hindering the conduct of academic-sponsored trials for drug repurposing on rare-diseases: an analysis of six use cases.识别阻碍开展药物重用于罕见病的学术赞助试验的障碍：六个应用案例分析。
Trials. 2022 Sep 15;23(1):783. doi: 10.1186/s13063-022-06713-y.
2
Timelines to initiate a phase III trial across the globe: a sub-analysis of the APHINITY trial.在全球启动III期试验的时间表：APHINITY试验的亚组分析。
Ecancermedicalscience. 2022 Apr 29;16:1379. doi: 10.3332/ecancer.2022.1379. eCollection 2022.
3
Challenges in Repurposing Drugs in COVID-19 Pandemic. Debating on Potential New Refinements.

本文引用的文献

1
A sponsor's experience with the Voluntary Harmonization Procedure for clinical trial applications in the European Union.申办者在欧盟临床试验申请自愿协调程序方面的经验。
Nat Rev Drug Discov. 2011 May;10(5):393. doi: 10.1038/nrd3202-c1.
2
Hartmut krafft. Interview by Bethan Hughes.哈特穆特·克拉夫特。贝唐·休斯采访。
Nat Rev Drug Discov. 2010 Jun;9(6):426. doi: 10.1038/nrd3202. Epub 2010 May 14.
2019冠状病毒病大流行中药物重新利用面临的挑战。关于潜在新改进措施的讨论。
Front Pharmacol. 2020 Oct 28;11:559996. doi: 10.3389/fphar.2020.559996. eCollection 2020.
4
Development in the number of clinical trial applications in Western Europe from 2007 to 2015: retrospective study of data from national competent authorities.2007年至2015年西欧地区临床试验申请数量的发展情况：对各国主管部门数据的回顾性研究
BMJ Open. 2017 Jul 10;7(7):e015579. doi: 10.1136/bmjopen-2016-015579.