首页|Influence of two-period cross-over design on the bioequivalence study of gefitinib tablets in beagle dogs
Influence of two-period cross-over design on the bioequivalence study of gefitinib tablets in beagle dogs
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NSTL
Elsevier
Generally, two-period cross-over design is used in bioequivalence (BE) study. High intra-subject variability of gefitinib was reported in a clinical BE study, and significant changes in gefitinib exposures were observed among different periods in our previous BE study in dogs. Therefore, commercial gefitinib tablets from the same batch were used in the present study and assigned to two groups: the testing drug (GF1) group and the reference drug (GF2) group. A single-oral-dose, two-period cross-over study with a 7-day washout (approximately 24 half-lives) under fasting condition was conducted in 12 dogs to explore the factors.
NSTL
Elsevier
