Handling High Variability in BE Studies: Design, Statistical Models, and Regulatory Strategies
Handling High Variability in BE Studies: Design, Statistical Models, and Regulatory Strategies Strategies for Managing High Variability in Bioequivalence Studies Introduction: The Challenge of High Variability in BA/BE Bioequivalence (BE) studies are crucial for ensuring that a generic formulation matches its reference product in pharmacokinetic performance. However, certain drugs exhibit high intra-subject variability in key…