This method for evaluation of tolerability when studying drug bioequivalence has been proposed. While its developing a generalized block diagram for carrying out the research in accordance with the requirements of ICH GCP and the algorithm of statistical planning and evaluation of tolerability/safety have been proven. The peculiarities and implementation possibilities of this algorithm have been shown. For the mixed model of the indicators determination in the study of BE the method of tolerability evaluation has been developed and the quantitative scale of equivalence assessment has been substituated. The scheme of the combined data sets formation for each of the indicators in the cross-model bioequivalence studies has been proposed and the method of statistical comparison of safety for a single dose of generic and the reference medicine have been proposed.
Key words: clinical trial, bioequivalence, coefficient, assessment, tolerability
