Statistical Considerations: Alternate Designs and Approaches for Bioequivalence Assessments

The great majority of bioequivalence (BE) studies measure drug concentrations in body fluids, such that products can be compared within an individual using crossover designs. In some rare circumstances, this approach is either not possible or impractical. For example, drugs with long half-lives may not be amenable to a crossover design or studies where a clinical endpoint is required in patients because of insufficient blood concentrations. In these cases a parallel design may be used.