Foreign Manufacturing of Generics: FDA Oversight and Standards in 2025
Dec 15 2025
The 80-125% Rule: Understanding Bioequivalence Confidence Intervals
Explains the 80-125% bioequivalence rule, clarifying that it measures drug absorption rates (AUC/Cmax) via 90% confidence intervals, not ingredient amounts. Covers exceptions for NTI drugs and common misconceptions.
