针对abrocitinib的药理动力学进行以患者为中心的微抽样:使用Tasso设备跨越多个分析物的测试桥梁
Sakambari Tripathy1, Katty X Wan2, Mohamed H Shahin1
1Pfizer Inc., 445 Eastern Point Road, Groton, CT 06340, USA.
Bioanalysis
|September 5, 2024
概括
塔索装置可以从毛细血管血液中准确测量abrocitinib及其代谢物. 这种微量采样方法与传统的静脉抽血方法具有很高的一致性,支持其在儿科研究中的应用.
科学领域:
- 药理动力学 药理动力学
- 分析化学 分析化学
- 临床诊断 临床诊断 临床诊断
背景情况:
- 阿布罗西替尼是需要治疗药物监测的重要药物.
- 传统的静脉血液采样可能具有侵入性和挑战性,尤其对儿科患者来说.
- 微采样设备为收集血液样本提供了一个不那么侵入性的替代方案.
研究的目的:
- 评估使用Tasso设备进行毛细血管血液采集以测量abrocitinib及其代谢物的可行性.
- 为了确定毛细血管和静脉血液采样方法之间的测试一致性.
- 评估Tasso设备对于未来涉及abrocitinib的儿科研究的适用性.
主要方法:
- 使用Tasso-SST®和Tasso+设备收集了毛细血管血液样本.
- 收集了静脉血液样本进行比较.
- 测量了abrocitinib及其代谢物 (M1,M2,M4) 的度,使用两种样本类型的验证试验.
- 测试一致性和药理学参数生物等价性 (AUC_last,C_max) 进行了统计评估.
主要成果:
- 在三个单独的测试中,在所有四种分析物质的毛细血管血清和静脉血度之间观察到高相关系数 (>0.98).
- 药物动力学参数,包括曲线下的面积 (AUC_last) 和最大度 (C_max),在比较毛细血管和静脉样本时符合生物等价性标准.
- 塔索设备在采样和分析量化方面表现出可靠的性能.
结论:
- 塔索装置可用于采集毛细血管血液样本,用于abrocitinib和代谢物分析.
- 毛细血管和静脉采样之间的测试一致性和生物等价性支持使用Tasso设备.
- 使用Tasso设备以患者为中心的微量采样是未来对abrocitinib儿科研究的可行选择.
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