Using Mitra sampling to support first-in-human pharmacokinetic evaluations for PF-07059013
Aim: A sensitive and selective method for the determination of PF-07059013 in dried blood collected by Mitra™ tips was developed and qualified from 50 to 50,000 ng/ml. Materials & methods: PF-07059013 is isolated from 10 μl of human dried blood by extraction with methanol and analyzed by HPLC-MS/MS. Results & conclusions: In addition to routine validation elements, impact of hematocrit and Mitra tip's lot-to-lot variation on assay accuracy were evaluated. The qualified method was used in one clinical study with excellent performance. Correlation coefficient between blood concentrations obtained from liquid-incurred blood samples and dried-incurred blood samples is 0.95. Clinical Trial Registration: NCT04323124 (ClinicalTrials.gov).
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:15 |
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| Enthalten in: |
Bioanalysis - 15(2023), 17 vom: 16. Sept., Seite 1083-1094 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Lee, Kimberly C [VerfasserIn] |
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| Links: |
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| Themen: |
Assay concordance |
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| Anmerkungen: |
Date Completed 18.09.2023 Date Revised 18.09.2023 published: Print-Electronic ClinicalTrials.gov: NCT04323124 Citation Status MEDLINE |
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| doi: |
10.4155/bio-2023-0066 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM360836461 |
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| 500 | |a ClinicalTrials.gov: NCT04323124 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Aim: A sensitive and selective method for the determination of PF-07059013 in dried blood collected by Mitra™ tips was developed and qualified from 50 to 50,000 ng/ml. Materials & methods: PF-07059013 is isolated from 10 μl of human dried blood by extraction with methanol and analyzed by HPLC-MS/MS. Results & conclusions: In addition to routine validation elements, impact of hematocrit and Mitra tip's lot-to-lot variation on assay accuracy were evaluated. The qualified method was used in one clinical study with excellent performance. Correlation coefficient between blood concentrations obtained from liquid-incurred blood samples and dried-incurred blood samples is 0.95. Clinical Trial Registration: NCT04323124 (ClinicalTrials.gov) | ||
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| 700 | 1 | |a Lim, Chay Ngee |e verfasserin |4 aut | |
| 700 | 1 | |a Clarke, Stephen |e verfasserin |4 aut | |
| 700 | 1 | |a Potts, Daniel |e verfasserin |4 aut | |
| 700 | 1 | |a Holmes, Kevin |e verfasserin |4 aut | |
| 700 | 1 | |a Gonzalez, Pilar |e verfasserin |4 aut | |
| 700 | 1 | |a Kavetska, Olga |e verfasserin |4 aut | |
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