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: | |
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Medienart: |
E-Artikel |
Erscheinungsjahr: |
2020 |
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Erschienen: |
2020 |
Enthalten in: |
Zur Gesamtaufnahme - volume:12 |
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Enthalten in: |
Bioanalysis - 12(2020), 13 vom: 12. Juli, Seite 893-904 |
Sprache: |
Englisch |
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Beteiligte Personen: |
Roadcap, Brad [VerfasserIn] |
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Links: |
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Themen: |
6K6L7E3F1L |
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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 |
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doi: |
10.4155/bio-2020-0074 |
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funding: |
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PPN (Katalog-ID): |
NLM312255586 |
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520 | |a 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 | ||
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700 | 1 | |a Carter, Keynu |e verfasserin |4 aut | |
700 | 1 | |a Dube, Neal |e verfasserin |4 aut | |
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700 | 1 | |a Vazvaei, Faye |e verfasserin |4 aut | |
700 | 1 | |a Bateman, Kevin |e verfasserin |4 aut | |
700 | 1 | |a Woolf, Eric |e verfasserin |4 aut | |
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