Metrics to characterize concentration-time profiles in single- and multiple-dose bioequivalence studies -- Basic statistical considerations -- Assessment of average bioequivalence in the RT/TR design -- Power and sample size determination for testing average bioequivalence in the RT/TR design -- Presentation of bioequivalence studies -- Designs with more than two formulations -- Analysis of pharmacokinetic interactions -- Population and individual bioequivalence -- Equivalence assessment for clinical endpoints.
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