國家衛生研究院 NHRI:Item 3990099045/4508
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    題名: A Bayesian noninferiority approach to evaluation of bridging studies
    作者: Liu, J;Hsueh, H;Hsiao, C
    貢獻者: Division of Biostatistics and Bioinformatics
    摘要: A bridging study defined by The International Conference on Harmonization E5 is usually conducted in the new region only after the test product has been approved for commercial marketing in the original region due to its proven efficacy and safety. In this paper, 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 to the population of the new region. Information on efficacy, safety, dosage, and dose regimen of the original region cannot be concurrently obtained from the local bridging studies but are available in the trials conducted in the original region. A Bayesian noninferiority approach is therefore proposed to incorporate the data generated in the original region to evaluate bridging evidence by the local bridging studies and assess similarity between the new and original regions. Methods for sample size determination for the bridging study are also proposed.
    日期: 2004-12
    關聯: Journal of Biopharmaceutical Statistics. 2004 Dec;14(2):291-300.
    Link to: http://dx.doi.org/10.1081/bip-120037180
    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=2642561923
    顯示於類別:[蕭金福] 期刊論文
    [劉仁沛(1998-2002)] 期刊論文

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