Document Classification

Section Type: RESULTS

Text: Validation tests indicate that the 2-point LSS model developed for the reference formulation predicts accurately (R2 > 0. 90) : (a) the individual AUC0-72 for the test formulation in the same group of volunteers ; (b) the individual AUC0-72 for the same reference formulation in another bioequivalence study in Brazilian volunteers ; (c) the average AUC0-72 reported in seven additional international studies performed under protocols similar to the present investigation ; (d) the individual AUC0-72 corresponding to concentration data points provided by a first-order compartmental pharmacokinetic model, when the relative values of either the absorption rate (Kabs) or the bioavailability (F) model parameters were set at 0. 85 or 0. 6, of their respective original values.