食蟹猴血液微量取样及血浆PK参数与常规取样的比较

IF 1.3 4区 医学 Q4 PHARMACOLOGY & PHARMACY
Simone Bertani, Alberto Donadi, Jessica Franchi, Federica Vinco, Rossella Cardin, Denise Federico, Alessia Tagliavini, Simone Zannoni, Marco Pergher, Michela Pecoraro, Massimo Breda
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引用次数: 0

摘要

微量采样是一种减少体积的采样方法,已成功地在国际协调会议(ICH)层面引起关注,并为其在毒代动力学(TK)研究中的应用提供了既定的益处。这些改进的采样技术侵入性较小,在大型动物物种中提高了动物福利(改进)。为了评估药物的血浆浓度是否受到血液取样方法的影响,对食蟹猴的传统股静脉取样方法和尾静脉微量取样方法进行了比较。四种药物(根据酸碱和分布体积特性选择)在非人灵长类动物中的药代动力学参数(Cmax、Tmax和AUC)是相关的。使用标准LC-MS/MS方法对血浆样品进行定量,在分析真实样品之前,有资格评估其精密度和准确性。这项工作中报告的结果证明了微采样在支持非人灵长类动物PK/TK研究中的适用性。数据显示,使用标准程序从股静脉采血和从尾静脉微量取样后测试的药物暴露是相关的,不受酸碱特性和分布体积的影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Blood microsampling in cynomolgus monkey and evaluation of plasma PK parameters in comparison to conventional sampling

Microsampling, a reduced volume sampling method, has successfully gained attention at the International Conference on Harmonization (ICH) level and established benefits support its use in Toxicokinetic (TK) studies. These improved sampling techniques are less invasive and in large animal species improve animal welfare (refinement). To evaluate if the plasma concentrations of drugs were influenced by the blood sampling method, the traditional method from femoral vein and microsampling from tail vein in Cynomolgus monkeys were compared. The pharmacokinetic parameters (Cmax, Tmax and AUC) of four drugs (selected based on acid-base and volume of distribution properties) in non-human primate were correlated. The plasma samples were quantified using standard LC-MS/MS methods, qualified to evaluate the precision and accuracy before the analysis of real samples.

The results reported in this work demonstrated the suitability of microsampling in supporting PK/TK studies in non-human primates. The data show that the exposure of drugs tested after blood collection using standard procedure from femoral vein and microsampling from tail vein is correlated and is not influenced by acid-base characteristics and volume of distribution.

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来源期刊
Journal of pharmacological and toxicological methods
Journal of pharmacological and toxicological methods PHARMACOLOGY & PHARMACY-TOXICOLOGY
CiteScore
3.60
自引率
10.50%
发文量
56
审稿时长
26 days
期刊介绍: Journal of Pharmacological and Toxicological Methods publishes original articles on current methods of investigation used in pharmacology and toxicology. Pharmacology and toxicology are defined in the broadest sense, referring to actions of drugs and chemicals on all living systems. With its international editorial board and noted contributors, Journal of Pharmacological and Toxicological Methods is the leading journal devoted exclusively to experimental procedures used by pharmacologists and toxicologists.
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