生物分析および生物医学ジャーナル

The Pharmacokinetics Evaluation and Bioequivalence of new Docetaxel Injections and Taxotere using Healthy Rats

Abstract

Rong Wang, Xiao-Yu Wu, Hua Xie, Juan-Hong Zhang, Jun Ma, Xian-Dong Men, Juan Wang, Jun-Li Zhang, Wen-Bing Li and Zheng-Ping Jia

The docetaxel of sterile freeze-dried powder inject ions was new developed injections due to overcome some drawb acks of Taxotere. We has been evaluated the pharmacokine tic properties and bioequivalence of the docetaxel of s terile freeze-dried powder injections and Taxotere by high ly selective and accurate LC-MS/MS method in healthy r ats. The pharmacokinetic parameters and bioequivalence o f two injections were obtained by the profession software (DAS, version 2.0). The 90% CIs for the In-transformed ra tios of C max : AUC 0-t and AUC 0~8 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 paramet ers of the two injections’, meanwhile docetaxel of sterile freeze- dried powder injections appeared to be bioequivalen t to Taxotere in healthy rats. The result was beneficial ly to further study the pharmacokinetics and bioequivalen ce of the human in the future research.