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夏天下雨了

金虫 (小有名气)

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[交流] 中译英（药代方面的）

单剂量口服10mg两种规格格列吡嗪制剂后，以辉瑞制药有限公司（中国.大连）生产的格列吡嗪控释片为对照，哈尔滨市神龙中药药物研究所生产的格列吡嗪缓释胶囊的生物利用度为100.7%，生物利用度符合要求。经方差分析显示两种制剂的药代动力学参数处理间与周期间无显著差异，进一步用双单侧t检验和（1-2a）置信区间法检验结果显示两种制剂的Tmax，Cmax、AUC和MRT接受生物等效的假设，说明两种制剂生物等效

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1楼 2011-03-09 10:53:21

已阅回复此楼关注TA 给TA发消息送TA红花 TA的回帖

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至尊木虫 (职业作家)

夏天下雨了(金币+20, 翻译EPI+1): 好，谢谢 2011-03-09 11:31:10

After a single oral dose of 10mg of glipizide of two specifications of formulations, by using glipizide controlled-release tablets manufactured by Pfizer Pharmaceutical Co., Ltd. (China. Dalian) as control, bioavailability of glipizide sustained-release capsules manufactured by Harbin Institute of Dragon Chinese medicines was determined as 100.7% and met the related requirements. Analysis of variance showed that no significant difference was found between pharmacokinetic parameters of both formulations so as for as for treatments and cycles, and further test results from two one-sided t test and (1-2a) confidence interval method on Tmax, Cmax, AUC and MRT of both formulations showed reliability of the hypothesis of bioequivalence. From above, a conclusion can be made that the two preparations are bioequivalent.

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