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A novel approach for bioequivalence test using bivariate confidence ellipse method: I


, : A novel approach for bioequivalence test using bivariate confidence ellipse method: I. Chinese Pharmaceutical Journal 45(4): 351-365

A novel approach employing the 90% confidence ellipse decision making principle for the bioequivalence test of drug products using C-max and AUC- infin simultaneously was described. The equation and the figure of the ellipse were obtained by the aid of a personal computer. The performance of the method was compared with the conventional univariate test methods using twelve bioequivalence studies conducted in Taiwan. Since the bioavailability relevant parameters are highly correlated variables, the confidence region for the decision making in the univariate tests appears to be variable from one bioequivalence study to another. Unlike the ambiguous overall confidence region usually encountered with the univariate tests in dealing with the correlated variables, the bivariate confidence ellipse method could provide clear-cut decision, unambiguous probability, consistent confidence region for decision and more information about the difference of population means in the bioequivalence test. The relationship between the vectors of the test and reference products were visualized to facilitate the inference of the test results. The equation of the confidence ellipse enabled the exact judgement for the test vectors scattering on the borderline of the ellipse in the figure. The method also allowed the detection of the possible outlier. The results also revealed that the major bioavailability problem in common in the domestic drug products was the rate of absorption and not the extent of absorption. The deficiency in the biopharmaceutical quality of drug products suggested the importance of formulation studies in products development.

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