Clinical Application of Volumetric Absorptive Microsampling to the Gefapixant Development Program

作者：Brad Roadcap, Azher Hussain, Dan Dreyer, Keynu Carter, Neal Dube, Yang Xu, Melanie Anderson, Erwin Berthier, Faye Vazvaei, Kevin P. Bateman, Eric Woolf · 发表于：Bioanalysis · 年份：2020 · DOI：10.4155/bio-2020-0074 · 被引用次数：29 · 研究领域：Biosimilars and Bioanalytical Methods、Pharmaceutical studies and practices、Asthma and respiratory diseases

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.