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.