| 内源性物质药物的定量测定及生物等效性评价研究进展 |
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| 引用本文： | 张煊,谢小青,刘婷立,宋冬梅.内源性物质药物的定量测定及生物等效性评价研究进展[J].中国新药杂志,2011(22). |
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| 作者姓名： | 张煊 谢小青 刘婷立 宋冬梅 |
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| 作者单位： | 沈阳亿灵医药科技有限公司; |
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| 摘 要： | 从定量分析和方法验证的角度来看,生物样品中内源性化合物的定量测定是非常复杂和困难的,而内源性药物的生物等效性评价同样也有其特殊性。文中通过对国内外文献资料进行调研、分析和总结,详细综述了内源性药物的生物分析方法及生物等效性试验设计和评价方法,并对面临的不同问题提出针对性解决方法。本文提供的一些思路和方法,对内源性药物的生物样品分析及生物等效性评价有重要意义。
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| 关 键 词： | 内源性物质 生物标志物 定量测定 生物等效性 |
Quantitative determination and bioequivalence assessment of the drugs as endogenous compounds |
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| ZHANG Xuan,XIE Xiao-qing,LIU Ting-li,SONG Dong-mei.Quantitative determination and bioequivalence assessment of the drugs as endogenous compounds[J].Chinese Journal of New Drugs,2011(22). |
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| Authors: | ZHANG Xuan XIE Xiao-qing LIU Ting-li SONG Dong-mei |
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| Institution: | ZHANG Xuan,XIE Xiao-qing,LIU Ting-li,SONG Dong-mei(E·living Pharmaceutical Company Limited of Shenyang,Shenyang 110179,China) |
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| Abstract: | The quantitative determination of endogenous compounds in biological samples is more complicated and difficult in aspects of both analytical methods and the validation.The literature of the domestic and overseas was investigated,analyzed and summarized.In this paper,we reviewed in detail the quantitative determination methods of endogenous compounds in biological samples,study design and assessment of the bioequivalence of endogenous drugs.A number of different strategies had been employed to overcome the c... |
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| Keywords: | endogenous compounds biomarker quantitative determination bioequivalence |
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