Tag: FDA bioequivalence

Partial AUC (pAUC) is a sophisticated pharmacokinetic tool used by the FDA and EMA to ensure generic drugs match brand-name versions in early drug release-critical for safety and efficacy. Learn how it works, why it's replacing old metrics, and what it means for generic drug development.

Crossover trial designs are the standard method for proving generic drugs are bioequivalent to brand-name versions. They reduce sample sizes, improve accuracy, and are required by the FDA and EMA for most bioequivalence studies.