| 内源性药物尿药生物等效性的试验设计和分析方法 |
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| 引用本文： | 许羚,赵佳,李禄金,杨娟,何迎春,吕映华,刘红霞,郑青山.内源性药物尿药生物等效性的试验设计和分析方法[J].中国临床药理学杂志,2011,27(10). |
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| 作者姓名： | 许羚 赵佳 李禄金 杨娟 何迎春 吕映华 刘红霞 郑青山 |
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| 作者单位： | 1. 上海中医药大学药物临床研究中心,上海,201203
2. 辽宁中医药大学附属第二医院,沈阳,110034 |
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| 基金项目： | 国家科技支撑计划基金资助项目(2008BAI51B03); 上海市教委基金资助项目(J50303、09JW17); 上海市高校中医内科学E-研究院基金资助项目(E03008) |
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| 摘 要： | 目的以枸橼酸钾为例,介绍内源性药物的尿药生物等效性试验(BE)的设计和分析方法。方法根据FDA关于内源性药物BE研究相关指南及相关文献,以枸橼酸钾尿药BE研究为实例,探讨其研究流程、质量监控、剂量选择、样本采集以及数据分析等关键问题。结果在枸橼酸钾BE研究中,用单剂量、双交叉设计,对试验期间的饮食和活动进行标准化控制,用同一周期的给药前的内源性物质作为基线,校正尿药排泄量,最后用24 h尿药累积排泄量(Ae0-24h)、最大尿药排泄速率(Rmax)进行生物等效性分析。结论内源性药物BE研究,在设计上更为复杂,饮食和生理因素对结果影响大,需要基线校正,数据波动明显。尿药参数以Ae0-t和Rmax为主,而Tmax和T1/2没有实际意义。
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| 关 键 词： | 内源性药物 生物等效性 枸橼酸钾 药代动力学 |
Design and analysis of the bioequivalence trial of endogenous drugs based on urine data |
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| XU Ling,ZHAO Jia,LI Lu-jin,YANG Juan,HE Ying-chun,LV Ying-hua,LIU Hong-xia,ZHENG Qing-shan.Design and analysis of the bioequivalence trial of endogenous drugs based on urine data[J].The Chinese Journal of Clinical Pharmacology,2011,27(10). |
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| Authors: | XU Ling ZHAO Jia LI Lu-jin YANG Juan HE Ying-chun LV Ying-hua LIU Hong-xia ZHENG Qing-shan |
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| Institution: | XU Ling1,ZHAO Jia2,LI Lu-jin1,YANG Juan1,HE Ying-chun1,LV Ying-hua1,LIU Hong-xia1,ZHENG Qing-shan1 (1.Center for Drug Clinical Research,Shanghai University of Chinese Medicine,Shanghai 201203,China,2.The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang 110034,China) |
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| Abstract: | Objective To introduce the design and analysis of the bioequivalence(BE) of endogenous drugs by the urine data of potassium citrate.Methods According to the FDA documents on the clinical BE study of endogenous drugs and other literature,the key issues including study flow,dietary and housing considerations,the dose choice,collection of samples and data analysis,were discussed in the bioequivalence study of potassium citrate.Results The BE of potassium citrate was designed as a single-dose and two-way crosso... |
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| Keywords: | endogenous drugs bioequivalence potassium citrate pharmacokinetics |
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