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The pharmacokinetics evaluation and bioequivalence of new docetaxel injections and taxotere using healthy rats
4th World Congress on Bioavailability and Bioequivalence: Pharmaceutical R&D Summit
May 20-22, 2013 DoubleTree by Hilton, Beijing, China
Zheng-Ping Jia
AcceptedAbstracts: J Bioequiv Availab
Abstract:
The docetaxel of sterile freeze-dried powder injections was of Taxotere. We has been evaluated the pharmacokinetic properties and bioequivalence of the docetaxel of sterile freeze-dried powder injections and Taxotere by highly selective and accurate LC-MS/MS method in healthy rats. The pharmacokinetic parameters and bioequivalence of two injections were obtained by the profession software (DAS, version 2.0). The 90% CIs for the In-transformed ratios of Cmax: AUC0-t and AUC0-∞ were 101.3%- 104.1%, 99.8% 100.8% and 99.4-100.6%, respectively (all, p < 0.001). In this study, we attained the pharmacokinetic parameters of the two injections?, meanwhile docetaxel of sterile freezedried powder injections appeared to be bioequivalent to Taxotere in healthy rats. The result was beneficially to further study the pharmacokinetics and bioequivalence of the human in the future research.