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happykeren2008(金币+30,VIP+0):谢谢再次帮助！
第一段 请参考：
Single administration of the Tolerance test: 26 healthy volunteers, men and women account for half of, according to their weight and gender,were randomly assigned to six-dose group (A group, B group, C group, D group, E Group, F Group ). A Group 2; B group, C group four in each, D group, E Group 6 each; F Group 4. The light's incremental costs (modified Fibonacci) increased administration, the groups were coated Andiconazole cream 2% × 2g, 2% × 4g, 4% × 4g, 4% × 6g, 6% × 6g, 6% × 7g. Each of the volunteers only accept a corresponding dose, small doses first, after each dose of no adverse reactions, then the next dose used to observe the response and tolerance the health body may does after given of Andiconazole cream.
Multiple (cumulative) administration's tolerance test: six healthy volunteers were coated Andiconazole cream 2% × 4g daily, for 7 d, observed the response and tolerance after health body administration of Andiconazole cream.
Pharmacokinetics test: choose a single administration tolerance test in the No. 2-dose group (2% × 4g) of the two cases pre-trial, If not detected plasma concentration, then choose the two cases No. 3-dose group a single administration the test in (4% × 4g),to pre-test subjects, according to pre-test results to review and amend the original design of the sampling points. If still not detected plasma concentration ,that may show few Andiconazole cream was absorbed into the blood through the skin, then stop the single administration pharmacokinetics trial.
During the administration tolerance tests,at the same time pharmacokinetics, select multiple administration tolerance test of six volunteers, Continuous administration four days, in section 5, 6, 7 days before delivery collecting blood samples, the 7th days after administration at different times (based on a single administration of the pharmacokinetics test results) collecting blood samples, using LC-MS-MS determinate the Andiconazole concentration in plasma. |
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