The structural error-in-equation model to evaluate individual bioequivalence.
Individual bioequivalence is assessed using an extension of the classical structural equation model, known as the error-in-equation model. This procedure estimates the relationship between individual means, as well as the variance-covariance parameters, of the bioavailabilities measurement model, by considering individual means related through a straight line with a random term, whereas the classical structural equation considers a deterministic linear relationship. We discuss the implications of this approach in terms of the bioavailabilities measurement model and how to test the overall hypothesis of individual bioequivalence. Both models are compared in a simulation study and a case example is presented.
Carrasco
Josep L
JL
Bioestadística, Departament de Salut Pública, Universitat de Barcelona, Casanova, 143 08036 Barcelona, Spain. jlcarrasco@ub.edu
Jover
Lluís
L
D000704:Analysis of Variance; D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data; D003198:Computer Simulation; D016001:Confidence Intervals; D003627:Data Interpretation, Statistical; D016013:Likelihood Functions; D015233:Models, Statistical; D015983:Selection Bias; D013810:Therapeutic Equivalency