Tag: bioequivalence

Jan, 24 2026

Complex Generic Formulations: Challenges in Proving Bioequivalence

Complex generics face major hurdles in proving bioequivalence due to their intricate formulations and local delivery mechanisms. Unlike simple pills, these drugs require advanced testing methods, regulatory alignment, and deep scientific understanding to ensure they work as well as the brand name.

Dec, 18 2025

Generic Drug Approval Standards: Safety, Quality, and Strength Requirements Explained

Generic drugs must meet the same safety, strength, and quality standards as brand-name drugs. Learn how the FDA ensures bioequivalence, manufacturing consistency, and patient safety through rigorous testing and inspections.