國家衛生研究院 NHRI:Item 3990099045/12902
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    题名: Use of tolerance intervals for assessing biosimilarity
    作者: Chen, C;Hsiao, CF
    贡献者: Institute of Population Health Sciences
    摘要: A biosimilar is a biological product that is highly similar to an existing approved reference drug and has no clinically meaningful difference from it. Biosimilars are composed of or derived from living cells or organisms. Therefore, they are often sensitive to slight variations in the manufacturing process. Consequently, in demonstrating biosimilarity, it might be inappropriate to focus solely on the mean difference, or ratio of means, while ignoring the variabilities associated with the test and reference products. It is important to account for the entire population of clinical outcomes. Thus, we propose using the concept of tolerance intervals and related hypothesis testing for assessing biosimilarity. Our approach has the advantage of considering entire populations associated with both groups. A real example is used to illustrate our proposed method, and our approach is more stringent than those that employ confidence intervals. This is specifically the case when the mean difference of two drugs is not sufficiently large, but the biosimilar has a higher variability than that in the reference drug.
    日期: 2020-11
    關聯: Statistics in Medicine. 2020 Nov;39(26):3806-3822.
    Link to: http://dx.doi.org/10.1002/sim.8695
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0277-6715&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000555285500001
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85088938119
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