Using Mitra sampling to support first-in-human pharmacokinetic evaluations for PF-07059013-Reference-Cited by-同舟云学术

Using Mitra sampling to support first-in-human pharmacokinetic evaluations for PF-07059013

Published:2023-09 Issue:17 Volume:15 Page:1083-1094
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Lee Kimberly C¹,Wan Katty X¹,Barricklow Jason¹,Lim Chay Ngee¹,Clarke Stephen²,Potts Daniel²,Holmes Kevin²,Gonzalez Pilar²,Kavetska Olga¹

Affiliation:

1. Pfizer Inc., Groton, CT 06340, USA

2. York Bioanalytical Solutions, Upper Poppleton, York, YO26 6QR, UK

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 )

Funder

Pfizer

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

https://www.future-science.com/doi/pdf/10.4155/bio-2023-0066

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