Tag: narrow therapeutic index

6 Feb 2026
by Preethika Shanmugham
14 Comments

NTI Generics: How Different Countries Regulate Narrow Therapeutic Index Drugs

NTI generics like warfarin and phenytoin require strict regulatory oversight due to their narrow safety margins. This article explores how the FDA, EMA, Health Canada, and other global regulators handle these drugs, including key differences in bioequivalence standards, approval processes, and real-world challenges.