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Local tolerance and sensitization studies External or histopathological evaluation of injection sites revealed no evidence of irritation in the singledose, repeated-dose or intermittent-dose studies. A tolerance study in rabbits used i.v. , paravenous p.v .; intradermal and intra-arterial (i.a.) administration of solutions of docetaxel in 0.9% aqueous NaCI containing polysorbate 80 at concentrations which were up to three times higher than those used in man; the results of this study indicated good tolerance by the i.a. and i.v. route and adequate tolerance by the p.v. route. Sensitization studies in mice, guinea pigs and rabbits revealed no evidence for sensitization, whereas a mild reaction was observed following intradermal re-challenge of docetaxel- pre-treated rabbits. In conclusion, the results of irritation and sensitization studies suggest a good tolerance and the absence of a signi白cant senslt1Za tion potential of the i. v. formulations of docetaxel Overall, the results of the preclinical toxicity studies indicate that the principal toxicological effects of docetaxel are compatible with the pharmacological (antimitotic) activity of the taxoid class of antineoplastic compounds.However,there were species-specific differences in the tolerance to the drug and in the susceptibility of principal target tissues. The results of the preclinical safety evaluations suggest that the monkey, in which hematopoietic effects (neutropenia) are the dose-limiting toxicity and in which i. v. administration of solutions containing polysorhate HO are well tolerated , may he the most suitahle large animal model for predicting the principal toxicities of docetaxel in man. The results of the acute toxicity study in dogs served as a hasis for the entry dose in man. Following recommendations of the :National Cancer Institute one third of the 'toxic dose low' in dogs (15mg/m2，i. e 5mg/m 2 ， was selected as the initial dose level for phase 1 clinical trials. |
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2楼2014-09-17 16:24:57