Lakhasly

In our previous single dose two-period cross-over bioequivalence study for gefitinib generic products in dogs under fasting condition, the results also did not match the acceptance criteria.Analysis of variance (ANOVA) revealed that there were significant differences between two periods and between individuals.A single-oral-dose, two-period, cross-over bioequivalence study was carried out in 12 Beagle dogs, with a washout interval of 7 days, approximately 24 half-lives (Mckillop et al., 2004).

In our previous single dose two-period cross-over
bioequivalence study for gefitinib generic products in dogs under fasting
condition, the results also did not match the acceptance criteria. Analysis of variance (ANOVA) revealed that there were significant differences between two periods and between individuals.
An optimized method was employed in dogs to explore the influence
of the two-period cross-over design on the bioequivalence of gefitinib
under a fasting state. Commercial Gefitinib tablets (IRESSA®) from the
same batch were assigned to two groups: the testing drug (GF1) group
and the reference drug (GF2) group. A single-oral-dose, two-period,
cross-over bioequivalence study was carried out in 12 Beagle dogs, with
a washout interval of 7 days, approximately 24 half-lives (Mckillop
et al., 2004). The measurement of gefitinib pharmacokinetic was conducted using a sensitive, rapid, and robust LC–MS/MS method. The
investigation of the variability between periods as well as other factors
might help to elucidate these non-bioequivalences for gefitinib tablets.