Tag: bioequivalence standards

Bioequivalence Explained: FDA Requirements to Prove Generic Drug Equivalence

Bioequivalence Explained: FDA Requirements to Prove Generic Drug Equivalence

25 Jan 2026 by Arturo Dell

Bioequivalence ensures generic drugs work the same as brand-name ones. The FDA requires strict testing of absorption rates using Cmax and AUC metrics, with a 80-125% confidence interval. This science-backed standard keeps generics safe, effective, and affordable.

Generic Drug Absorption Rates: What the 80-125% Rule Really Means

Generic Drug Absorption Rates: What the 80-125% Rule Really Means

20 Dec 2025 by Arturo Dell

The 80-125% rule for generic drugs isn't about ingredient amounts-it's about how your body absorbs the drug. Learn what this standard really means and why generics are just as safe and effective as brand-name drugs.