Analysis of the Variability of the Pharmacokinetics of the Long Half-Life Drug Amiodarone in Bioequivalence Studies

Abstract

The article provides an extensive analysis of the data obtained in bioequivalence studies, which can be considered for further evaluation in the development of general and individual therapeutic regimens. Concrete data obtained in two bioequivalence studies compared amiodarone formulations and included plasma levels of amiodarone and the active metabolite desethylamiodarone. The analysis included mean data and variability in plasma concentrations and pharmacokinetic parameters. In addition, a global and structural meta-analysis of the individual plasma level sets was performed. The half-life of amiodarone was not well defined and the total area below the plasma level curves was less appropriate for estimating bioequivalence.