Two-stage designs versus European scaled average designs in bioequivalence studies for highly variable drugs: Which to choose?
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DOI: 10.1002/sim.7452
Abstract: The usual approach to determine bioequivalence for highly variable drugs is scaled average bioequivalence, which is based on expanding the limits as a function of the within-subject variability in the reference formulation. This requires separately… read more here.
Keywords: bioequivalence; highly variable; two stage; variable drugs ... See more keywords