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    政大機構典藏 > 商學院 > 統計學系 > 期刊論文 >  Item 140.119/18175
    Please use this identifier to cite or link to this item: http://nccur.lib.nccu.edu.tw/handle/140.119/18175

    Title: Bayesian Approach to Evaluation of Bridging Studies
    Authors: 薛慧敏
    Liu, Jen-pei;Hsiao, Chin-Fu;Hsueh, Hueymiin
    Date: 2002-08
    Issue Date: 2008-12-19 14:52:59 (UTC+8)
    Abstract: 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.
    Relation: Journal of Biopharmaceutical Statistics, 12(3),401-408
    Data Type: article
    DOI 連結: http://dx.doi.org/10.1081/BIP-120014568
    DOI: 10.1081/BIP-120014568
    Appears in Collections:[統計學系] 期刊論文

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