Regulatory Approaches for Bioequivalence Study of Highly Variable Drugs (HvD)
HvD pose a unique challenge in generic drug development due to their high intra-subject variability (CV > 30%) in pharmacokinetics. This variability complicates BE studies, requiring different regulatory agencies to adopt distinct approaches to ensure therapeutic equivalence without clinical hurdles. Key Regulatory Approaches for HvD Generic Drug Approval USFDA Approach – Reference-Scaled Average Bioequivalence (RSABE)…