Clinical application of volumetric absorptive microsampling to the gefapixant development program

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.

Errataetall:

ErratumIn: Bioanalysis. 2021 Mar;13(5):409. - PMID 33688751

Medienart:

E-Artikel

Erscheinungsjahr:

2020

Erschienen:

2020

Enthalten in:

Zur Gesamtaufnahme - volume:12

Enthalten in:

Bioanalysis - 12(2020), 13 vom: 12. Juli, Seite 893-904

Sprache:

Englisch

Beteiligte Personen:

Roadcap, Brad [VerfasserIn]
Hussain, Azher [VerfasserIn]
Dreyer, Dan [VerfasserIn]
Carter, Keynu [VerfasserIn]
Dube, Neal [VerfasserIn]
Xu, Yang [VerfasserIn]
Anderson, Melanie [VerfasserIn]
Berthier, Erwin [VerfasserIn]
Vazvaei, Faye [VerfasserIn]
Bateman, Kevin [VerfasserIn]
Woolf, Eric [VerfasserIn]

Links:

Volltext

Themen:

6K6L7E3F1L
Dried blood
Gefapixant
Journal Article
Pyrimidines
Sulfonamides
Tasso OnDemand
VAMS

Anmerkungen:

Date Completed 31.05.2021

Date Revised 14.06.2021

published: Print-Electronic

ErratumIn: Bioanalysis. 2021 Mar;13(5):409. - PMID 33688751

Citation Status MEDLINE

doi:

10.4155/bio-2020-0074

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM312255586