Department of Pharmacokinetics, Merck & Co. Inc., Pharmacodynamics & Drug Metabolism, West Point, PA 19486, USA.
Tasso Inc. 1631 15th Ave W, Seattle, WA 98119, USA.
Bioanalysis. 2020 Jul;12(13):893-904. doi: 10.4155/bio-2020-0074. Epub 2020 Jul 10.
In this paper we show the application of the Tasso OnDemand™, a novel automated sample collection device, in conjunction with volumetric absorptive microsampling (VAMS) for the development of gefapixant, a P2X3 receptor antagonist currently under clinical development for the treatment of refractory and unexplained chronic cough and endometriosis-related pain. A LC-MS/MS bioanalytical method was developed and validated using VAMS to support this development program. This method was utilized in a drug-drug interaction study to establish a mathematical bridging relationship with data obtained from a validated plasma assay used to support the program. The VAMS bioanalytical method and the predictability of the mathematical relationship is reported and discussed here.
在本文中，我们展示了 Tasso OnDemand™ 的应用，这是一种新型的自动化样本采集设备，与体积吸收微采样（VAMS）结合使用，用于开发 gefapixant，这是一种目前正在临床开发用于治疗难治性和原因不明的慢性咳嗽和子宫内膜异位症相关疼痛的 P2X3 受体拮抗剂。开发了一种 LC-MS/MS 生物分析方法，并使用 VAMS 对其进行了验证，以支持该开发计划。该方法用于药物相互作用研究，以与使用经过验证的血浆分析方法获得的数据建立数学桥接关系，该方法用于支持该计划。本文报告并讨论了 VAMS 生物分析方法和数学关系的可预测性。
