Tag: bioequivalence

Dec, 19 2025

FDA Authorization of Generics: Legal Basis and Approval Process

Nina Falkner

Learn how the FDA legally authorizes generic drugs through the Hatch-Waxman Act and ANDA pathway, ensuring they're as safe and effective as brand-name drugs while cutting costs by up to 85%.

Dec, 9 2025

How to Compare Bioavailability and Bioequivalence in Generic vs Brand Drugs

Nina Falkner

Learn how bioavailability and bioequivalence ensure generic drugs work just like brand-name versions. Understand the science behind generic approval, real-world outcomes, and why these standards keep patients safe.

Nov, 16 2025

Generic vs Brand-Name Drugs: Key Differences Explained

Nina Falkner

Generic drugs save up to 85% on costs and are just as safe and effective as brand-name versions. Learn how the FDA ensures they work the same, why they look different, and when you might still need the brand.

Nov, 14 2025

The 80-125% Rule: Understanding Bioequivalence Confidence Intervals

Nina Falkner

The 80-125% rule ensures generic drugs perform like brand-name versions by measuring how much of the drug enters your bloodstream. It's not about pill strength-it's about absorption. Learn how regulators use confidence intervals to guarantee safety.