Average bioequivalence study designs
The most common designs for bioequivalence studies are replicated crossover, nonreplicated crossover, and parallel. In a parallel design, each subject receives only one formulation in randomized fashion, whereas in a crossover design each subject receives different formulations in different time periods. Crossover designs are further broken down into replicated and nonreplicated designs. In nonreplicated designs, subjects receive only one dose of the test formulation and only one dose of the reference formulation. Replicated designs involve multiple doses. A bioequivalence study should use a crossover design unless a parallel or other design can be demonstrated to be more appropriate for valid scientific reasons. Replicated crossover designs should be used for individual bioequivalence studies, and can be used for average or population bioequivalence analysis.
An example of a nonreplicated crossover design is the standard 2x2 crossover design described below.
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Recommended models for average bioequivalence