Tag: bioequivalence
International Perspectives on NTI Generics: Regulatory Approaches Compared
NTI generics require strict regulatory oversight due to their narrow safety margin. This article compares how the FDA, EMA, Health Canada, and others regulate these high-risk drugs, highlighting differences in bioequivalence standards, approval timelines, and substitution rules.
Dec 19 2025
Population Pharmacokinetics: How Data Proves Drug Equivalence Across Patient Groups
Population pharmacokinetics uses real-world patient data to prove drug equivalence across diverse groups - not just healthy volunteers. Learn how it's changing generic drug approval and personalized dosing.
Nov 25 2025
