The main objective of the work is the application of experimental design and some simple tests (t-ratios) in the evaluation of bioequivalence of two treatments. It is performed the assessment of the effectiveness of different treatments administered to two groups of patients: the control group and the test group. The comparison of the control group that received the reference medication with the control group test, which received the drug under study, using a crossover experimental design. It was performed an analysis using t-ratios and considering and inter-subject variability formulation of the probabilistic model, where the specification of tests for detection of carryover and period effects were considered. The application to a practical case consisted in the validation of the hypothesis of the proposed model took place, where the effects carryover and period were not significant when considering usual levels of significance. About the treatments, we could conclude that there was statistical significance to affirm that the studied pharmaceuticals were not bioequivalent.

The second author was partially supported by Fundação para a Ciência e Tecnologia, I.P. (FCT) [ISTAR Projects: UIDB/04466/2020 and UIDP/04466/2020].

Experimental design,Clinical trials,Bioequivalence