Using Mitra sampling to support first-in-human pharmacokinetic evaluations for PF-07059013.
Bioanalysis
; 15(17): 1083-1094, 2023 Sep.
Article
in En
| MEDLINE
| ID: mdl-37584365
ABSTRACT
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).Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Tandem Mass Spectrometry
/
Dried Blood Spot Testing
Limits:
Humans
Language:
En
Journal:
Bioanalysis
Year:
2023
Type:
Article
Affiliation country:
United States