國家衛生研究院 NHRI:Item 3990099045/12900
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    题名: Use of a two-sided tolerance interval in the design and evaluation of biosimilarity in clinical studies
    作者: Chiang, C;Chen, CT;Hsiao, CF
    贡献者: Institute of Population Health Sciences
    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.
    日期: 2021-01
    關聯: Pharmaceutical Statistics. 2021 Jan;20(1):175-184.
    Link to: http://dx.doi.org/10.1002/pst.2065
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=1539-1604&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000565601400001
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85089999883
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