國家衛生研究院 NHRI:Item 3990099045/3549
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    题名: A noninferiority test for treatment-by-factor interaction with application to bridging studies and global trials
    作者: Liu, JP;Lin Jr, R;Hsieh, E
    贡献者: Division of Biostatistics and Bioinformatics
    摘要: Similarity of the treatment effects of a drug product among different intrinsic and extrinsic ethnic, geographic, or demographic factors is important not only to regulatory agencies in the approval of the drug but also to the public health. Examples include bridging studies in different regions, the extrapolation from the adult population to the pediatric subpopulation, or comparisons between different geographic regions within a global trial. It is an issue of evaluation of the treatment-by-factor interaction. However, assessment of similarity is not to detect the existence of treatment-by-factor interaction but rather to evaluate whether the magnitude of treatment-by-factor interaction is within a clinically allowable margin. As a result, we propose two testing procedures for the noninferiority hypothesis of the treatment-by-factor interaction to assess the similarity of the treatment effects among ethnical or demographic factors. Two numeric data sets illustrate applications of the proposed methods to different scenarios under different circumstances. Copyright ? 2009 Drug Information Association, Inc.
    日期: 2009
    關聯: Drug Information Journal. 2009;43(1):11-16.
    Link to: http://www.nxtbook.com/nxtbooks/dia/druginformationjournal0109/
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000262340300003
    Cited Times(Scopus): http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=59849120157
    显示于类别:[劉仁沛(1998-2002)] 期刊論文

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