國家衛生研究院 NHRI:Item 3990099045/6728
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    题名: Statistical methods for bridging studies
    作者: Chow, SC;Chiang, C;Liu, JP;Hsiao, CF
    贡献者: Division of Biostatistics and Bioinformatics;Division of Clinical Trial Statistics
    摘要: In 1998, the International Conference on Harmonization (ICH) published a guidance to facilitate the registration of medicines among ICH regions including the European Union, the United States, and Japan by recommending a framework for evaluating the impact of ethnic factors on a medicine’s effect, such as its efficacy and safety at a particular dosage and dose regimen (ICH E5, 1998). The purpose of ICH E5 is not only to evaluate the ethnic factor influence on safety, efficacy, dosage, and dose regimen, but also more importantly to minimize duplication of clinical data and allow extrapolation of foreign clinical data to a new region. In this article, statistical methods for evaluation of bridging studies based on the concepts of consistency (Shih, 2001), reproducibility/generalizability (Shao and Chow, 2002), the weighted Z-tests for the design of bridging studies (Lan et al., 2005), and similarity between the new and original region based in terms of positive treatment effect (Hsiao et al., 2007) are studied. The relative merits and disadvantages of these methods are compared by several examples.
    日期: 2012-10
    關聯: Journal of Biopharmaceutical Statistics. 2012 Oct;22(5):903-915.
    Link to: http://dx.doi.org/10.1080/10543406.2012.701578
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=1054-3406&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000308983200004
    Cited Times(Scopus): http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=84866272166
    显示于类别:[蕭金福] 期刊論文
    [劉仁沛(1998-2002)] 期刊論文

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