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JOURNALS // Informatika i Ee Primeneniya [Informatics and its Applications] // Archive

Inform. Primen., 2019 Volume 13, Issue 3, Pages 58–62 (Mi ia610)

This article is cited in 1 paper

Evaluation of the significance level in Schuirmann's test for checking the bioequivalence hypothesis in missing data conditions

T. V. Zakharovaab, A. A. Tarkhova

a 1Department of Mathematical Statistics, Faculty of Computational Mathematics and Cybernetics, M. V. Lomonosov Moscow State University, 1-52 Leninskiye Gory, GSP-1, Moscow 119991, Russian Federation
b Institute of Informatics Problems, Federal Research Center “Computer Science and Control” of the Russian Academy of Sciences, 44-2 Vavilov Str., Moscow 119333, Russian Federation

Abstract: The bioequivalence hypothesis testing is the important task in pharmacokinetics. It helps to make a decision about the equivalence of the reproduced drug to the reference drug. One of the problems of bioequivalence studies is the availability of missing data. A small amount of data entails the inability to delete a data sample with missing data. Therefore, there is a task to estimate the impact of missing data on bioequivalence testing task, in particular, to estimate the significance level. The main method of the bioequivalence hypothesis testing is Schuirmann's two one-sided tests procedure. The article shows the significance level evaluation of this procedure in the case of missing data. The evaluation component, depending on the level of data completeness, is shown in the explicit form.

Keywords: bioequivalence, significance level, type I error, missing data, Schuirmann's two one-sided tests procedure.

Received: 09.05.2019

DOI: 10.14357/19922264190309



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