國家衛生研究院 NHRI:Item 3990099045/11596
English  |  正體中文  |  简体中文  |  全文笔数/总笔数 : 12189/12972 (94%)
造访人次 : 955486      在线人数 : 730
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/3990099045/11596


    题名: Two-stage designs of bridging studies
    作者: Hsiao, CF;Tsou, HH;Liu, JP;Wu, YJ
    贡献者: Institute of Population Health Sciences
    摘要: In recent years, global collaboration has led to a new strategy for drug development. After a pharmaceutical product has been approved for commercial marketing in one region (e.g., the United States or European Union) based on its proven ef‚cacy and safety, the pharmaceutical sponsor might seek registration of the product in a new region, such as an Asian country. However, to extrapolate the original clinical data to new populations, the differences in race, diet, environment, culture, and medical practice among regions might cause impact upon a medicine’s effect. In 1998, the International Conference on Harmonisation (ICH) published a guideline titled “Ethnic Factors in the Acceptability of Foreign Clinical Data” known as ICH E5 to provide a general framework for evaluating the impact of ethnic factors on a medicine’s effect such as its ef‚cacy and safety at a particular dosage or dose regimen. More speci‚cally, the ICH E5 guideline suggests that a bridging study be conducted in the new region to extrapolate the inference based on the foreign ef‚cacy data or safety data to a new region.
    日期: 2012-07-26
    關聯: Design and Analysis of Bridging Studies. 2012 Jul 26;Chapter 2:17-32.
    Link to: http://dx.doi.org/10.1201/b12277-7
    显示于类别:[蕭金福] 圖書
    [鄒小蕙] 圖書

    文件中的档案:

    档案 描述 大小格式浏览次数
    NPH2018122604.pdf1147KbAdobe PDF269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