Informatics and Applications
2019, Volume 13, Issue 3, pp 58-62
EVALUATION OF THE SIGNIFICANCE LEVEL IN SCHUIRMANN'S TEST FOR CHECKING THE BIOEQUIVALENCE HYPOTHESIS IN MISSING DATA CONDITIONS
- T. V. Zakharova
- A. A. Tarkhov
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.
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[+] About this article
Title
EVALUATION OF THE SIGNIFICANCE LEVEL IN SCHUIRMANN'S TEST FOR CHECKING THE BIOEQUIVALENCE HYPOTHESIS IN MISSING DATA CONDITIONS
Journal
Informatics and Applications
2019, Volume 13, Issue 3, pp 58-62
Cover Date
2019-09-30
DOI
10.14357/19922264190309
Print ISSN
1992-2264
Publisher
Institute of Informatics Problems, Russian Academy of Sciences
Additional Links
Key words
bioequivalence; significance level; type I error; missing data; Schuirmann's two one-sided tests procedure
Authors
T. V. Zakharova  ,  and A. A. Tarkhov
Author Affiliations
National Research University Higher School of Economics, 34 Tallinskaya Str., Moscow 123458, Russian Federation
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
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