Bioequivalence Analysis
The detailed pharmacokinetic parameters and the 90% CI for the ratio of
the logarithmically transformed pharmacokinetic parameters are described
in Table 3 . Based on the multivariate ANOVA no significant
difference was found in both Cmax and
AUC0-t between the test and reference formulations. It
is shown that the 90% CIs were 91.40-107.57% for Cmax,
91.69-103.63% for AUC0-t, 92.27-104.37% for
AUC0-∞. In addition, the GMRs for Cmaxand AUC were all within 0.80-1.25, and Tmax values were
comparable between test and reference formulations under fasting or fed
condition. The detailed results are shown in Table 3 . As
indicated in Figure 4 , the individual difference of log
Cmax and log AUC0-t values was in a
narrow range for the T and T formulations. Therefore, the test
formulation was considered bioequivalent to the reference formulation.
Table 3 Bioequivalence evaluation for the main pharmacokinetic
parameters of gefitinib under fasting and fed conditions