Tag: FDA bioequivalence
Jan, 12 2026
Narrow Therapeutic Index Drugs: Why Bioequivalence Rules Are Tighter for These Medications
Narrow therapeutic index drugs require stricter bioequivalence standards because small differences in dosage can cause serious harm. Learn how the FDA, EMA, and Health Canada regulate generics like warfarin, levothyroxine, and digoxin to ensure patient safety.
Dec, 15 2025
Partial AUC: Advanced Bioequivalence Measurements Explained
Partial AUC is a precise pharmacokinetic tool used to ensure generic drugs match the brand’s absorption timing - critical for extended-release painkillers, ADHD meds, and abuse-deterrent formulations. Learn how regulators use it to protect patient safety.