RSABE
Differences Between RSABE and Traditional ABE Approaches
Scaling of Bioequivalence Limits RSABE (reference-scaled average bioequivalence): The limits are scaled based on the intra-subject variability of the reference drug. For drugs with higher variability, the acceptance criteria are relaxed, meaning the 90% confidence interval for the pharmacokinetic parameter ratios can be wider than the standard 80–125% used in ... Read More
Highly Variable Drugs and RSABE
Highly variable drugs (HVDs) are a category within pharmaceuticals that exhibit significant intra-subject variability in pharmacokinetic parameters such as peak concentration (Cmax) and the area under the concentration-time curve (AUC). Specifically, a drug is classified as highly variable when the intra-subject variability, represented by the coefficient of variation (CV), exceeds ... Read More