Clinical Application of Volumetric Absorptive Microsampling to the Gefapixant Development Program

Abstract

<jats:p> 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. </jats:p>

homeRNA: A self-sampling kit for the collection of peripheral blood and stabilization of RNA

“…Compared to other blood collection methods, users report much lower pain thresholds when using the Tasso-SST™ or similar devices that collect from the upper arm. [18][19][20][21] The authors note that the serum separator tube (SST) gel (included in the Tasso-SST™ collection tube) is not necessary for RNA stabilization and analysis. In fact, a device or tube containing EDTA or another anticoagulant would be preferable to prevent clotting, and we note varying degrees of clotting observed in our returned samples.…”

How the Covid-19 Pandemic is Changing Clinical Trial Conduct and Driving Innovation in Bioanalysis

“…In recent years, we have seen the development of novel polymer-based drying sorbents that resolve hematocrit issues [40]. There are also new ways to collect capillary blood beyond fingerstick sampling, which could simplify collection and decrease pain [41][42][43].…”

“…In addition, many novel sampling devices collect smaller volumes of capillary blood or other matrices. Developing assays with smaller volume needs will enable new technology applications with devices that may be less invasive and less painful [ 42 , 44 , 47 ].…”

Will patient-centric sampling become the norm for clinical trials after COVID-19?

“…It also reduces patient burden and provides opportunities for wider and more-diverse participation in clinical trials. There are multiple examples of the successful application of patient-centric sampling for diagnostic testing and in clinical trials [1][2][3][4][5][6] . However, adoption of patient-centric sampling in clinical trials has been slow, in part because of ongoing questions about the quality of sampling, sample stability and comparability to standard sampling methods.…”

“…However, these sampling challenges can potentially be overcome with rigorous patient training and by the use of sample-collection devices that make sample collection easier and more convenient and that improve accuracy of data collection (e.g., automatic time stamping). Some of these novel devices, which allow the collection of samples at home or at remote locations [1][2][3][4] , have already been successfully used in phase 3 clinical trials 5,6 .…”