Pharmacokinetics Of Trastuzumab After Intravenous Administration In Rhesus Monkeys

To evaluate the quality of domestic trastuzumab impersonally and investigate its pharmacokinetics characteristic in order to warrant the design and optimization of future clinical research, we studied its pharmacokinetics after intravenous administration in rhesus monkeys.We studied the bioequivalence of domestic and imported Trastuzumab in rhesus monkey according to an open 2-way crossover study design, and investigated the kinetics characteristics of domestic trastuzumab by single-dose and multiple-dose, respectively. Serum concentrations of Trastuzumab were determined by an ELISA method we established, and also we testified the methodology particularly. Calculated pharmacokinetics parameters and compared bioequivalence by statistical moment method combined with 3P97 software.The assay has sufficient sensitivity, precision, accuracy and specificity for the analysis of rhesus monkey serum samples, making this an ideal assay for pre-clinical investigations. The result of the statistical analysis showed that the 2 preparations were bioequvalent. The change of trastuzumab in vivo exhibited nonlinear kinetics over the administration dosage range, which was l~16mg per kilogram. Concentrations of trastuzumab under designed project were above the clinical recommended target concentration all through the experimental period.