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使用干血斑测定萘普生:人血浆与人体血液干血斑的评估及药代动力学比较。

Determination of naproxen using DBS: evaluation & pharmacokinetic comparison of human plasma versus human blood DBS.

作者信息

Youhnovski Nikolay, Michon Josée, Latour Sylvain, Mess Jean-Nicholas, Bergeron Annik, Furtado Milton, Rufiange Marianne, Guibord Pascal, Lefebvre Marc, Macarthur Robert B, Garofolo Fabio

机构信息

Algorithme Pharma Inc., 575 Armand-Frappier, Laval, Quebec, H7V 4B3, Canada.

出版信息

Bioanalysis. 2010 Aug;2(8):1501-13. doi: 10.4155/bio.10.51.

Abstract

BACKGROUND

Dried blood spots (DBS) sampling is a well-known technology for qualitative determination such as DNA analysis and screening of newborn metabolic disorders. The scientific community has recently expressed interest in applying the DBS technique for quantitative determination of drugs in biological fluid.

RESULTS

Two new bioanalytical assays were developed and validated for the determination of naproxen in human plasma and in DBS samples using liquid chromatography coupled with tandem MS. Furthermore, plasma and DBS clinical samples were collected from four subjects enrolled as part of a bioequivalence study. Concentration data for plasma and DBS samples were determined and pharmacokinetic (PK) profiles in plasma and in DBS samples were compared.

CONCLUSIONS

A strong correlation between PK data obtained by the DBS and conventional plasma method was observed, which makes DBS a valuable technique for further naproxen bioavailability and PK investigations and studies.

摘要

背景

干血斑(DBS)采样是一种广为人知的用于定性测定的技术,如DNA分析和新生儿代谢紊乱筛查。科学界最近对将DBS技术应用于生物流体中药物的定量测定表现出兴趣。

结果

开发并验证了两种新的生物分析方法,用于使用液相色谱-串联质谱法测定人血浆和DBS样品中的萘普生。此外,从作为生物等效性研究一部分招募的四名受试者中收集了血浆和DBS临床样品。测定了血浆和DBS样品的浓度数据,并比较了血浆和DBS样品中的药代动力学(PK)曲线。

结论

观察到通过DBS获得的PK数据与传统血浆方法之间有很强的相关性,这使得DBS成为进一步进行萘普生生物利用度和PK研究的有价值技术。

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