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Use of a two‐sided tolerance interval in the design and evaluation of biosimilarity in clinical studies
Author(s) -
Chiang Chieh,
Chen ChiTian,
Hsiao ChinFu
Publication year - 2020
Publication title -
pharmaceutical statistics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.421
H-Index - 38
eISSN - 1539-1612
pISSN - 1539-1604
DOI - 10.1002/pst.2065
Subject(s) - equivalence (formal languages) , tolerance interval , confidence interval , statistics , type i and type ii errors , interval (graph theory) , sample size determination , mathematics , population , econometrics , reliability engineering , medicine , engineering , environmental health , discrete mathematics , combinatorics
Summary 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.