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两种用于大鼠药物发现PK研究的血液微量采样方法的评估。

Evaluation of two blood microsampling approaches for drug discovery PK studies in rats.

作者信息

Luo Yongyi, Korfmacher Walter, Ho Stacy, Shen Liduo, Wang Jie, Wu Zhongtao, Guo Yang, Snow Gregory, O'Shea Thomas

机构信息

Drug Metabolism & Pharmacokinetics, Sanofi, Second Avenue, Waltham, MA 02451, USA.

Agilux, 1 Innovation Drive, Worcester, MA 01605, USA.

出版信息

Bioanalysis. 2015 Sep;7(18):2345-2359. doi: 10.4155/bio.15.126. Epub 2015 Sep 23.

Abstract

BACKGROUND

Serial sampling in discovery rat PK studies could be performed via capillary microsampling (CMS) of blood or by using the Mitra™ device to collect dried blood samples.

RESULTS

Blood CMS results were compared with Mitra sampling results for four test compounds dosed in rat PK studies. The PK profiles obtained from CMS sampling were found to be very similar to those obtained from the Mitra sampling. For 15-µl blood CMS samples, freezing before the dilution step was found to be acceptable.

CONCLUSION

Blood CMS using 15-µl glass capillary microsamples works well for serial blood sampling in rat PK studies. The Mitra microsampling device provides an alternative method for collecting 10 µl of blood as a dried blood sample.

摘要

背景

在发现性大鼠药代动力学(PK)研究中,可通过血液毛细管微量采样(CMS)或使用Mitra™装置采集干血样进行连续采样。

结果

在大鼠PK研究中,将四种受试化合物的血液CMS结果与Mitra采样结果进行了比较。发现从CMS采样获得的PK图谱与从Mitra采样获得的图谱非常相似。对于15微升血液CMS样品,发现在稀释步骤之前冷冻是可以接受的。

结论

使用15微升玻璃毛细管微量样品的血液CMS在大鼠PK研究的连续血液采样中效果良好。Mitra微量采样装置为采集10微升血液作为干血样提供了一种替代方法。

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