Use of a two‐sided tolerance interval in the design and evaluation of biosimilarity in clinical studies

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Title:	Use of a two‐sided tolerance interval in the design and evaluation of biosimilarity in clinical studies
Authors:	Chiang, Chieh;Chen, Chi-Tian;Hsiao, Chin-Fu
Date:	2020-09
Issue Date:	2022-05-09 12:10:42 (UTC+8)
Abstract:	In assessing biosimilarity between two products, the question to ask is always “How similar is similar?” Traditionally, the equivalence of the means between products is the primary consideration in a clinical trial. This study suggests an alternative assessment for testing a certain percentage of the population of differences lying within a prespecified interval. In doing so, the accuracy and precision are assessed simultaneously by judging whether a two-sided tolerance interval falls within a prespecified acceptance range. We further derive an asymptotic distribution of the tolerance limits to determine the sample size for achieving a targeted level of power. Our numerical study shows that the proposed two-sided tolerance interval test controls the type I error rate and provides sufficient power. A real example is presented to illustrate our proposed approach.
Relation:	Pharmaceutical Statistics 20(1), p.175-184
DOI:	10.1002/pst.2065
Appears in Collections:	[Graduate Institute & Department of Mathematics] Journal Article

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