Clinical application of volumetric absorptive microsampling to the gefapixant development program

Bioanalysis ◽  
2020 ◽  
Vol 12 (13) ◽  
pp. 893-904 ◽  
Author(s):  
Brad Roadcap ◽  
Azher Hussain ◽  
Dan Dreyer ◽  
Keynu Carter ◽  
Neal Dube ◽  
...  
Keyword(s):  
Development Program ◽  
P2x3 Receptor ◽  
Interaction Study ◽  
Sample Collection ◽  
Mathematical Relationship ◽  
Drug Interaction Study ◽  
Bioanalytical Method ◽  
Collection Device ◽  
Plasma Assay ◽  
Volumetric Absorptive Microsampling

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.

scholarly journals Clinical Evaluation of the Torq Zero Delay Centrifuge System for Decentralized Blood Collection and Stabilization

Diagnostics ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 1019
Author(s):  
Kyungjin Hong ◽  
Gabriella Iacovetti ◽  
Ali Rahimian ◽  
Sean Hong ◽  
Jon Epperson ◽  
...  
Keyword(s):  
Clinical Chemistry ◽  
Blood Collection ◽  
Test Results ◽  
Sample Collection ◽  
Rapid Separation ◽  
Cell Counts ◽  
Collection Device ◽  
Precision Study ◽  
Clinically Significant ◽  
Blood Specimens

Blood sample collection and rapid separation—critical preanalytical steps in clinical chemistry—can be challenging in decentralized collection settings. To address this gap, the Torq™ zero delay centrifuge system includes a lightweight, hand-portable centrifuge (ZDrive™) and a disc-shaped blood collection device (ZDisc™) enabling immediate sample centrifugation at the point of collection. Here, we report results from clinical validation studies comparing performance of the Torq System with a conventional plasma separation tube (PST). Blood specimens from 134 subjects were collected and processed across three independent sites to compare ZDisc and PST performance in the assessment of 14 analytes (K, Na, Cl, Ca, BUN, creatinine, AST, ALT, ALP, total bilirubin, albumin, total protein, cholesterol, and triglycerides). A 31-subject precision study was performed to evaluate reproducibility of plasma test results from ZDiscs, and plasma quality was assessed by measuring hemolysis and blood cells from 10 subject specimens. The ZDisc successfully collected and processed samples from 134 subjects. ZDisc results agreed with reference PSTs for all 14 analytes with mean % biases well below clinically significant levels. Results were reproducible across different operators and ZDisc production lots, and plasma blood cell counts and hemolysis levels fell well below clinical acceptance thresholds. ZDiscs produce plasma samples equivalent to reference PSTs. Results support the suitability of the Torq System for remotely collecting and processing blood samples in decentralized settings.

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