C57BL/6小鼠血浆中低电离药物pocapavir的定量方法的开发和验证

IF 1.8 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS

Bioanalysis Pub Date : 2025-03-01 Epub Date: 2025-03-21 DOI:10.1080/17576180.2025.2480533

Renmeng Liu, Ashley Davie, Elaine To, Yurong Lai

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引用次数: 0

摘要

背景：波卡帕韦是一种抗病毒药物，已显示出对脊髓灰质炎病毒的体外效力。有必要对其体内有效性和安全性进行研究。因此，开发一种灵敏可靠的生物分析方法来定量波卡韦药物水平并表征其药代动力学（PK）谱是势在必行的。研究设计与方法：针对帕帕韦电离效率低的特点，采用常压化学电离法（APCI）提高检测灵敏度。所开发的方法被验证并随后在小鼠PK研究中实施。结果：该方法是首个报道的波卡帕韦生物分析方法，按照良好实验室规范（GLP）的原则开发并通过了完整的方法验证，所有评价参数均符合规定的验收标准。结论：经过验证的生物分析方法适合于定量pocapavir，同时支持临床前和首次人体（FIH） PK表征的潜在应用。

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Development and validation of a sensitive method to quantify a poorly ionized drug, pocapavir, in C57BL/6 mouse plasma.

Background: Pocapavir is an antiviral agent that has shown in vitro potency against poliovirus. It necessitates investigation into its in vivo efficacy and safety profiles. Therefore, the development of a sensitive and reliable bioanalytical method to quantify pocapavir drug levels and characterize its pharmacokinetic (PK) profiles is imperative.

Research design and methods: Given pacapavir's low ionization efficiency, the utilization of atmospheric pressure chemical ionization (APCI) is employed to enhance the assay sensitivity. The developed method is validated and subsequently implemented in a mouse PK study.

Results: As the first reported bioanalytical method for pocapavir, the method is developed and validated through a full method validation in accordance with the principles of Good Laboratory Practice (GLP), with all evaluated parameters meeting the stipulated acceptance criteria.

Conclusions: The validated bioanalytical method is suitably equipped to quantify pocapavir while bolstering preclinical and potential applications for first-in-human (FIH) PK characterizations.

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来源期刊

Bioanalysis BIOCHEMICAL RESEARCH METHODS-CHEMISTRY, ANALYTICAL

CiteScore

3.30

自引率

16.70%

发文量

审稿时长

2 months

期刊介绍： Reliable data obtained from selective, sensitive and reproducible analysis of xenobiotics and biotics in biological samples is a fundamental and crucial part of every successful drug development program. The same principles can also apply to many other areas of research such as forensic science, toxicology and sports doping testing. The bioanalytical field incorporates sophisticated techniques linking sample preparation and advanced separations with MS and NMR detection systems, automation and robotics. Standards set by regulatory bodies regarding method development and validation increasingly define the boundaries between speed and quality. Bioanalysis is a progressive discipline for which the future holds many exciting opportunities to further reduce sample volumes, analysis cost and environmental impact, as well as to improve sensitivity, specificity, accuracy, efficiency, assay throughput, data quality, data handling and processing. The journal Bioanalysis focuses on the techniques and methods used for the detection or quantitative study of analytes in human or animal biological samples. Bioanalysis encourages the submission of articles describing forward-looking applications, including biosensors, microfluidics, miniaturized analytical devices, and new hyphenated and multi-dimensional techniques. Bioanalysis delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for the modern bioanalyst.