s-1743 and fimasartan

Bioequivalence tests are fundamental step in assessing the equivalence in bioavailability between a test and reference product. In practice, two separate linear mixed models (LMMs) with random subject effects, which have an area under the concentration-time curve (AUC) and the peak concentration (C. Three pharmacokinetic datasets, fixed-dose combination (naproxen and esomeprazole), tramadol and fimasartan data were analyzed. We compared the 90% confidence interval (CI) for the geometric mean ratio (GMR) of a test product to a reference product using the multivariate HGLM and two conventional separate LMMs.. We found that the 90% CIs for the GMRs of both AUC and C. This multivariate HGLM had good performance in the bioequivalence test with multiple endpoints. This method would provide a more reasonable option to reduce the 90% CI by adding correlation parameters and thus an advantage especially in evaluating the bioequivalence of highly variable drugs with broad 90% CIs.

Topics: Area Under Curve; Biological Availability; Biphenyl Compounds; Datasets as Topic; Drug Combinations; Esomeprazole; Humans; Linear Models; Male; Models, Statistical; Multivariate Analysis; Naproxen; Pyrimidines; Randomized Controlled Trials as Topic; Tetrazoles; Therapeutic Equivalency; Tramadol