Application of the NONMEM method to evaluation of the bioequivalence/bioavailability

Abstract

Bioequivalence of defferent products of the same drug is very important where many generic drug products are on the market. Data of bioequivalence tests have been analyzed using pharmacokinetic model independent parameters. However, model dependent methods merit being considered as an analysis method to assess bioequivalence/bioavailability. We have studied the application of NONMEM to evaluation of bioequivalence/bioavailability, which is one of the methods used for analysis of population pharmacokinetics. In this paper, decision-making rules in bioequivalence assessment, an application method of NONMEM to the evaluation of bioequivalence and the relationship between a decision-making rule and the NONMEM method were shown. The results of comparison of the confidence intervals for the difference in bioavailability estimated by NONMEM and a model independent method were summarized, which indicated the usefulness of the NONMEM method for evaluation of bioequivalence using experimental and obsevational data. Merits and demerits of NONMEM for assessing bioequivalence/bioavailability were discussed.