The calculation of probabilities in rejecting bioequivalence

Methods are given for deriving the lower and upper bounds of the probabilities for rejecting bioequivalence. Except when two formulations are nearly equal, the lower and upper bounds become very close and thus give an exact probability. The methods can be used in two- or higher-way crossover or parallel groups designs. One can also determine the sample size from the equations. The results are compared with the probabilities obtained by simulation.