Tag: Partial AUC

Partial AUC in Bioequivalence: How It Works and Why It Matters for Generic Drugs

Partial AUC measures drug exposure in specific time intervals to improve bioequivalence for complex formulations. It overcomes limitations of traditional metrics like Cmax and AUC. FDA and EMA require it for certain drugs. Challenges include higher sample sizes and precise time intervals. Essential for generic drug developers to prevent rejections.