Bioequivalence (BE) plays an important role in the drug development process. The bioequivalence studies are used to test if a reference drug (R) and a test drug (T) are equivalent. These tests are based upon some pharmacokinetic (PK) parameters. If there is no significant difference between the reference and the test drugs, then we can say that these two drugs are bioequivalent. The goal of this paper is to provide a statistical approach to test equivalence between T and R drugs in a univariate analysis and a multivariate analysis for five PK parameters  MANOVA was proposed for testing BE because it takes in consideration the inter-relation between the PK parameters at the same time, while ANOVA considers only the separate effect of each PK parameter. The results are achieved according to real data obtained from Central Administration for Pharmaceutical Affairs (CAPA), in Egypt .

bioequivalence, crossover design, ANOVA, MANOVA.