國家衛生研究院 NHRI:Item 3990099045/11592
English  |  正體中文  |  简体中文  |  全文笔数/总笔数 : 12189/12972 (94%)
造访人次 : 955512      在线人数 : 736
RC Version 6.0 © Powered By DSPACE, MIT. Enhanced by NTU Library IR team.
搜寻范围 查询小技巧：
  • 您可在西文检索词汇前后加上"双引号"，以获取较精准的检索结果
  • 若欲以作者姓名搜寻，建议至进阶搜寻限定作者字段，可获得较完整数据
    •  进阶搜寻
    主页 ‧ 登入 ‧ 上传 ‧ 说明 ‧ 关于NHRI ‧ 管理 到手机版


    jsp.display-item.identifier=請使用永久網址來引用或連結此文件: http://ir.nhri.org.tw/handle/3990099045/11592


    题名: Multiregional Clinical Trials
    作者: Tsong, Y;Tsou, HH
    贡献者: Institute of Population Health Sciences
    摘要: With increasing globalization in the development of medicines, developing strategies for when and how to address geographic variations of ef‚cacy and safety for product development has become essential. To shorten the time for drug development and regulatory approval, it would be desirable to conduct a trial for simultaneous drug development, submission, and approval around the world. Recently, the number of clinical trials simultaneously conducted in Asian countries, Europe, and the United States has increased signi‚cantly. In particular, the Japanese government has the initiative to participate in global development and international clinical studies. The 11th Q&A for the ICH E5 (ICH, 2006) guideline described points to consider for evaluating the possibility of bridging among regions in a multiregional trial and stated that “it may be desirable in certain situations to achieve the goal of bridging by conducting a multi-regional trial under a common protocol that includes suf‚cient numbers of patients from each of multiple regions to reach a conclusion about the effect of the drug in all regions.” Basically, a multiregional clinical trial is designed for two objectives. The ‚rst objective is to assess the ef‚cacy of the test treatment over all regions in the trial. The second objective is to bridge the overall effect of the test treatment to each of the regions in the trial.
    日期: 2012-07-26
    關聯: Design and Analysis of Bridging Studies. 2012 Jul 26;Chapter 11:219-234.
    Link to: https://www.taylorfrancis.com/books/9781439846353/chapters/10.1201/b12277-14
    显示于类别:[鄒小蕙] 圖書

    文件中的档案:

    档案 描述 大小格式浏览次数
    NPH2018122605.pdf4784KbAdobe PDF162检视/开启


    在NHRI中所有的数据项都受到原著作权保护.

    TAIR相关文章

    DSpace Software Copyright © 2002-2004  MIT &  Hewlett-Packard  /   Enhanced by   NTU Library IR team Copyright ©   - 回馈