Tag: NTI drugs
FDA Bioequivalence Standards for NTI Drugs: Special Requirements Explained
The FDA enforces stricter bioequivalence standards for narrow therapeutic index (NTI) drugs like warfarin, digoxin, and phenytoin, requiring tighter limits (90-111%) and replicate studies to ensure patient safety. These rules prevent dangerous fluctuations in blood levels that can occur with generics.
Combination NTI Drugs and Generic Availability: Coverage and Gaps
Combination NTI drugs offer powerful treatment but carry extreme risks when switched to generics. With no approved generic combinations in the U.S., patients face higher costs, more monitoring, and serious safety gaps.
