Pharmaceutical Education and Practice

Bioavailability & Bioequivalence Studies

Bioavailability means the rate and extent to which the active drug substance or therapeutic moiety is absorbed from a pharmaceutical form and becomes available at the site of action. For drugs intended to exhibit a systemic therapeutic effect, bioavailability can be more simply understood as the rate and extent to which a substance or its therapeutic moiety is delivered from a pharmaceutical form into the general circulation. Bioequivalence focus on the release of a drug substance from a drug product and subsequent absorption into systemic circulation. Bioequivalence studies are a surrogate marker for clinical effectiveness and safety data as it would not normally be practical to repeat clinical studies for generic products.

• Invitro bioequivalence
• Bioavailability metrics
• Waiver of invivo bioavailability
• Bioequivalence study protocols
• Genetic phenotyping
• Bioequivalence study design