Bioequivalence

The information provided to Research Subjects, Clinical Investigators, Institutional Review Boards, and Sponsors/Monitors/Contract Research Organizations is also applicable to Bioequivalence Facilities.

FDA Regulation

• Bioavailability and Bioequivalence Requirements (21 CFR Part 320)

Useful Links

• Office of Clinical Pharmacology and Biopharmaceutics
• Office of Generic Drugs