Bioavailability and Bioequivalence

Bioequivalence of Narrow Therapeutic Index Drugs

Bioequivalence studies for narrow therapeutic index (NTI) drugs focus on demonstrating equivalence in drug absorption, distribution, and elimination to ensure consistent therapeutic outcomes. NTI drugs have a narrow margin between efficacy and toxicity, making precise dosing critical. These studies require stringent bioanalytical methods and statistical analyses to assess bioequivalence within narrow confidence intervals.