Using Mitra sampling to supportfirst-in-human pharmacokinetic evaluationsfor PF-07059013: supplementary figure 1
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 misolated 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 liquidincurred blood samples and dried-incurred blood samples is 0.95.