Scaled Average Bioequivalence (SABE) for Highly Variable Drugs (HVDs)
While traditional Average Bioequivalence (ABE) works well for most drugs, some cases require advanced approaches. Certain drugs exhibit high intra-subject variability (>30% coefficient of variation, CV), making it difficult to demonstrate BE using traditional methods. SABE is a statistical approach that adjusts BE acceptance limits based on the drug’s inherent variability, preventing unnecessary study failures…