Bioavailability and Bioequivalence

Biowaivers and Regulatory Exemptions

Biowaivers are regulatory exemptions granted for certain bioequivalence studies, allowing for the approval of generic drugs without conducting comparative clinical trials. These waivers are based on the demonstration of similarity in drug absorption between the generic and reference products using in vitro dissolution testing or other surrogate measures. Biowaivers streamline the drug approval process, saving time and resources while maintaining confidence in the equivalence of generic medications, particularly for well-understood drugs with predictable pharmacokinetics.