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.
Highlights
Following oral administration to humans, amiodarone (AMD) is absorbed slowly and variably
Usual assessment of bioequivalence is performed in terms of mean plasma levels and pharmacokinetic parameters
Concentrations of AMD and dAMD in the time interval – h. Beyond this rst appearance, we must look for variability because it is very important for a particular patient if they are in the upper or lower part of the plasma level group, as the therapeutic and toxic e ects are dependent on drug concentrations
Summary
Following oral administration to humans, amiodarone (AMD) is absorbed slowly and variably. The bioavailability of AMD is approximately % [ ]. Peak plasma concentrations are reached in to h. The relationships between plasma concentrations and the pharmacodynamic e ect are very complex. It can appear in to days, but more often lasts one to three weeks, and even longer after dosing. AMD has a very large and variable volume of distribution, averaging about L/kg due to its extensive accumulation in various compartments, especially adipose tissue and highly perfused organs [ ]. A major metabolite of AMD, desethylamiodarone (dAMD), has been identi ed in humans. The main route of elimination is by hepatic excretion into the bile and signi cant enterohepatic circulation may occur
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