Поиск гендерных различий фармакокинетических параметров розувастатина в исследованиях биоэквивалентности воспроизведенных препаратов

We present the results of analysis of the influence of gender factor on the variability of pharmacokinetic parameters C max and AUC for rosuvastatin and on the results of bioequivalence studies. The analysis includes the results of 18 bioequivalence studies of rosuvastatin administration in 495 healthy volunteers (234 men and 261 women). Given the administration of two drugs by each participant, 1980 data sets were analyzed for C max and AUC values). The results obtained demonstrate that the bioequivalence of rosuvastatin reveals no statistically significant gender differences in the intra-individual variability of C max and AUC . No clear relationships have been established between the gender and frequency of detection of high intra-individual variability. In 28% of data obtained in men and women, differences were found between the pharmacokinetic parameters of the generic and reference drugs (manifested by more than 20% difference between the ratios of geometric mean T / R parameters C max and AUC ) but the analysis did not reveal statistically significant differences. Simulation analysis of influence of the gender factor on the results of bioequivalence studies of rosuvastatin showed that the frequency of non-equivalent results was 39% in men and 28 % in women. No relationship between the gender factor and the frequency of detecting non-equivalent results has been established (χ 2 = 0.125; p > 0.05).