Bioequivalence Tests Based on Individual Estimates Using Non-compartmental or Model-Based Analyses: Evaluation of Estimates of Sample Means and Type I Error for Different Designs

摘要

Purpose The main objective of this work is to compare the standard bioequivalence tests based on individual estimates of the area under the curve and the maximal concentration obtained by non-compartmental analysis (NCA) to those based on individual empirical Bayes estimates (EBE) obtained by nonlinear mixed effects models.