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 () 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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More From: Communications for Statistical Applications and Methods
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