Tag: bioequivalence
An ANDA is the FDA's pathway for approving generic drugs without repeating costly clinical trials. It saves patients billions annually by ensuring safe, effective copies of brand-name medications enter the market quickly.
Cmax and AUC are the two key metrics used to prove generic drugs work the same as brand-name versions. Cmax measures peak concentration, while AUC measures total exposure. Both must fall within 80%-125% to ensure safety and effectiveness.