國家衛生研究院 NHRI:Item 3990099045/11596
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    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
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