國家衛生研究院 NHRI:Item 3990099045/4509
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    题名: A group sequential approach to evaluation of bridging studies
    作者: Hsiao, C;Xu, J;Liu, J
    贡献者: Division of Biostatistics and Bioinformatics
    摘要: The International Conference on Harmonization (ICH) E5 guideline defines a bridging study as a supplementary study conducted in the new region to provide pharmacodynamic or clinical data on efficacy, safety, dosage, and dose regimen to allow extrapolation of the foreign clinical data to the population of the new region. Therefore, a bridging study 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. 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 is the information on efficacy, safety, dosage, and dose regimen of the original region that cannot be concurrently obtained from the local bridging studies but is available in the trials conducted in the original region. A group sequential approach is therefore proposed to overcome the issue of internal validity. In particular, we use the region as a group sequence to enroll the patients from the original region first and then to enroll patients from the new region subsequently. Methods for sample size determination for the bridging study in the new region are also proposed.
    日期: 2003
    關聯: Journal of Biopharmaceutical Statistics. 2003;13(4):793-801.
    Link to: http://dx.doi.org/10.1081/bip-120024210
    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=0141889798
    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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