Communications for Statistical Applications and Methods

The Korean Statistical Society (한국통계학회)
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Statistical Assessment of Biosimilarity based on the Relative Distance between Follow-on Biologics in the (k + 1)-Arm Parallel Design

  • Kang, Seung-Ho (Department of Applied Statistics, Yonsei University) ;
  • Shin, Wooyoung (Department of Applied Statistics, Yonsei University)
  • Received : 2015.07.17
  • Accepted : 2015.09.05
  • Published : 2015.11.30
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Abstract

A three-arm parallel design has been proposed to assess the biosimilarity between a biological product and a reference product using relative distance (Kang and Chow, 2013). The three-arm parallel design consists of two arms for the reference product and one arm for the biosimilar product. This paper extended the three-arm parallel design to a (k + 1)-arm parallel design composed of k (${\geq}3$) arms for the reference product and one arm for the biosimilar product. A new relative distance was defined based on Euclidean distance; consequently, a corresponding test procedure was developed based on asymptotic distribution. Type I error rates and powers were investigated both theoretically and empirically.

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References

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