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    請使用永久網址來引用或連結此文件: https://tkuir.lib.tku.edu.tw/dspace/handle/987654321/122704

    題名: Use of a two‐sided tolerance interval in the design and evaluation of biosimilarity in clinical studies
    作者: Chiang, Chieh;Chen, Chi-Tian;Hsiao, Chin-Fu
    日期: 2020-09
    上傳時間: 2022-05-09 12:10:42 (UTC+8)
    摘要: In assessing biosimilarity between two products, the question to ask is always “How similar is similar?” Traditionally, the equivalence of the means between products is the primary consideration in a clinical trial. This study suggests an alternative assessment for testing a certain percentage of the population of differences lying within a prespecified interval. In doing so, the accuracy and precision are assessed simultaneously by judging whether a two-sided tolerance interval falls within a prespecified acceptance range. We further derive an asymptotic distribution of the tolerance limits to determine the sample size for achieving a targeted level of power. Our numerical study shows that the proposed two-sided tolerance interval test controls the type I error rate and provides sufficient power. A real example is presented to illustrate our proposed approach.
    關聯: Pharmaceutical Statistics 20(1), p.175-184
    DOI: 10.1002/pst.2065
    顯示於類別:[數學學系暨研究所] 期刊論文


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