Bioavailability and bioequivalence: an FDA regulatory overview

Area of Science:

• Regulatory Science
• Pharmaceutical Sciences
• Drug Development

Background:

• Bioavailability and bioequivalence studies are essential throughout a drug's lifecycle.
• These studies are vital for both novel drugs and generic equivalents.
• They are also critical for assessing post-approval manufacturing changes.

Purpose of the Study:

• To review the regulatory science underpinning bioavailability and bioequivalence (BE) studies.
• To provide FDA recommendations for drug sponsors.
• To guide the establishment and demonstration of bioavailability and bioequivalence for pharmaceutical products.

Main Methods:

• The article frames the assessment of bioavailability and bioequivalence around three core questions.
• These questions address the primary study objective, appropriate testing methodologies, and required confidence in test outcomes.
• The review synthesizes FDA recommendations for drug sponsors.

Main Results:

• The review clarifies the critical role of bioavailability and bioequivalence studies in drug development.
• It highlights their importance for both new chemical entities and generic drugs.
• The article emphasizes their necessity in post-approval scenarios involving manufacturing modifications.

Conclusions:

• Understanding the regulatory science of bioavailability and bioequivalence is key for drug sponsors.
• The FDA provides specific recommendations to guide these critical studies.
• Successful completion of these studies ensures product quality and therapeutic equivalence.