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

C Lee K, X Wan K, Barricklow J, et al. | Bioanalysis, 15(17), 1083-1094, (2023)

Keywords: • assay concordance • dried blood • LC–MS/MS • microsampling • Mitra • qualification

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.

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