國家衛生研究院 NHRI:Item 3990099045/4511
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    题名: Bayesian approach to evaluation of bridging studies
    作者: Liu, J;Hsiao, C;Hsueh, H
    贡献者: Division of Biostatistics and Bioinformatics
    摘要: We address the issue of analysis of clinical data generated by the bridging study conducted in the new region to evaluate the similarity for extrapolation of the foreign clinical data. A bridging study is usually conducted in the new region only after the test product is approved for commercial marketing in the original region due to its proven efficacy and safety. Sufficient information on efficacy, safety, dosage, and dose regimen has already generated in the original region. The empirical Bayesian approach is proposed to synthesize the data generated by the bridging study and foreign clinical data generated in the original region for assessment of similarity between the new and the original regions. A method for sample size determination for the bridging study is also suggested. It can be shown that the total sample size is inversely proportional to the strength of the evidence for the efficacy presented in the original region and the proportion of the patients assigned to receive the test product in the bridging study.
    日期: 2002
    關聯: Journal of Biopharmaceutical Statistics. 2002;12(3):401-408.
    Link to: http://dx.doi.org/10.1081/bip-120014568
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=1054-3406&DestApp=IC2JCR
    Cited Times(Scopus): http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=0036428684
    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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