Validation of low-volume sampling devices for pharmacokinetic analysis: technical and logistical challenges and solutions

Abstract

While low-volume sampling technologies offer numerous advantages over venipuncture, implementation in clinical trials poses technical and logistical challenges. Bioanalytical methods were validated for measuring the concentration of crenezumab and etrolizumab in dried blood samples collected using Mitra and Tasso-M20. The data generated demonstrate that the concentrations of crenezumab and etrolizumab in dried blood collected by either device could be determined using calibrators prepared in serum. Drug concentrations from dried blood were converted to serum concentrations using patient hematocrit levels. Contract Research Organization experience in sample handling and analysis allowed us to compare differences between various low-volume sampling technologies. This study evaluated challenges and presented potential solutions for use of different low-volume sampling technologies for pharmacokinetic analysis.