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小丸丸9

铁虫 (正式写手)

应助: 0 (幼儿园)
金币: 777.5
散金: 77
红花: 1
帖子: 829
在线: 147.5小时
虫号: 3337955
注册: 2014-07-24
性别: MM
专业: 无机药物化学

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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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