Sample Size Determination for Repeated Measurements in Bioequivalence Test

When the measurement of outcome is unreliable or the cost of obtaining an additional subject is relatively high compared to the cost of obtaining an additional measurement from the same subject, it may be desirable to consider taking more than one measurement per subject to increase power or to minimize the cost in a clinical trial. When each subject in two comparison groups has a fixed number of repeated measurements, this paper develops an asymptotic procedure to calculate the number of subjects per group required to achieve a given power for an α-level bioequivalence test. Furthermore, Monte Carlo simulation is used to evaluate the accuracy of the approximate sample size calculation procedure and a brief discussion on how to determine the optimal number of repeated measurements is included.