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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)
  • 투고 : 2018.12.18
  • 심사 : 2019.07.20
  • 발행 : 2020.01.31

초록

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.

키워드

참고문헌

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