内源性物质药物的定量测定及生物等效性评价研究进展  

Quantitative determination and bioequivalence assessment of the drugs as endogenous compounds

作　　者：张煊[1] 谢小青[1] 刘婷立[1] 宋冬梅[1] 

机构地区：[1]沈阳亿灵医药科技有限公司,沈阳110179

出　　处：《中国新药杂志》2011年第22期2221-2228,共8页Chinese Journal of New Drugs

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。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 corresponding inherent bias.Considerations and methods are very meaningful to promote bioanalysis of the endogenous compounds and the evaluation of bioequivalence of endogenous drugs.

关 键 词：内源性物质 生物标志物 定量测定 生物等效性 

分 类 号：R917.4[医药卫生—药物分析学] R974[医药卫生—药学]