Uyeda Craig, Pham Roger, Fide Stacy, Henne Kirk, Xu Guifen, Soto Marcus, James Christopher, Wong Philip
Department of Pharmacokinetics & Drug Metabolism, Amgen, South San Francisco, CA 94080, USA.
Bioanalysis. 2011 Oct;3(20):2349-56. doi: 10.4155/bio.11.227.
The use of dried blood spot (DBS) sampling technique is of particular interest for drug discovery pharmacokinetic studies due to the small blood volume requirement. In addition, automated blood sampling is an attractive approach for rat pharmacokinetic studies as animal handling work is minimized. The goal of this study was to use an automated DBS sampler for automated blood collection and spotting onto DBS paper for pharmacokinetic studies in rats. AMG 517, a potent and selective vanilloid receptor antagonist, was dosed to rats (n = 3) intravenously and blood samples were collected at nine time points over a 24 h period using the automated DBS sampler. After drying, storage and shipment, the DBS samples were extracted and analyzed by LC-MS/MS.
The developed bioanalytical method for the analysis of DBS samples had good accuracy and precision within the context of a discovery, non-GLP analysis. The concentration-time data and pharmacokinetic parameters generated from automated spotted samples were very similar to those derived from manually spotted DBS samples. The manual DBS data were also comparable to plasma data after correction for blood-to-plasma ratio.
The automated DBS sampling is a promising technique for rodent pharmacokinetic studies and will improve the efficiency and quality of DBS sampling.
由于所需血量少,干血斑(DBS)采样技术在药物发现的药代动力学研究中特别受关注。此外,自动采血是大鼠药代动力学研究的一种有吸引力的方法,因为动物处理工作被减到最少。本研究的目的是使用自动DBS采样器进行自动采血并将血样点样到DBS滤纸上,用于大鼠的药代动力学研究。给大鼠(n = 3)静脉注射强效选择性香草酸受体拮抗剂AMG 517,并使用自动DBS采样器在24小时内的九个时间点采集血样。干燥、储存和运输后,对DBS样本进行提取并用LC-MS/MS分析。
所建立的用于分析DBS样本的生物分析方法在探索性、非GLP分析的背景下具有良好的准确度和精密度。自动点样样本生成的浓度-时间数据和药代动力学参数与手动点样的DBS样本非常相似。校正血-血浆比后,手动DBS数据也与血浆数据相当。
自动DBS采样是一种有前途的啮齿类动物药代动力学研究技术,将提高DBS采样的效率和质量。