Incorporating dried blood spot LC–MS/MS analysis for clinical development of a novel oncolytic agent

Abstract

Aim: Design and execution of a dried blood spot (DBS-LC–MS/MS) assay for pharmacokinetic analyses in oncology patients. Results & discussion: The methodology was validated to collect and store DBS samples from multiple clinical sites, and analyze blood with diverse hematocrit ranges (25–55) to match the potential patient population. Bridging data comparing DBS and plasma showed high degree of concordance with DBS:plasma ratios of 0.81, demonstrating no preferential uptake or association with cellular components of the blood. Pharmacokinetic analysis supporting clinical development was performed using 20 μl of blood collected as DBS. Incurred sample reanalysis showed high correlation. Conclusion: Successful validation of a DBS method and implementation in the clinic enabled pharmacokinetic analysis during the clinical development of a novel oncolytic agent in oncology patients.