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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.

pharmaceutical research

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