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http://dx.doi.org/10.29220/CSAM.2020.27.1.001

Statistical tests for biosimilarity based on relative distance between follow-on biologics for ordinal endpoints  

Yoo, Myung Soo (Department of Statistics, Sungkyunkwan University)
Kim, Donguk (Department of Statistics, Sungkyunkwan University)
Publication Information
Communications for Statistical Applications and Methods / v.27, no.1, 2020 , pp. 1-14 More about this Journal
Abstract
Investigations of biosimilarity between reference drugs and test drugs required statistical tests; in addition, statistical tests to evaluate biosimilarity have been recently proposed. Ordinal outcome data has been observed in research; however, appropriate statistical tests to deal with ordinal endpoints for biosimilar have not yet been proposed. This paper extends existing design for ordinal endpoints. Using measure of nominal-ordinal association and relative distances between drugs are defined so that testing procedures are developed. Through simulation studies, we investigate type I error rate and power to show the performance of our suggested method. Furthermore, a comparison between the statistical tests and other designs is proviede to show significance of ordinal endpoints.
Keywords
biosimilar; nominal-ordinal association; equivalence trials; three-arm parallel design;
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