Microsampling in pediatric studies: pharmacokinetic sampling for baricitinib (Olumiant™) in global pediatric studies

Abstract

Background: Managing blood volumes in pediatric studies is challenging and should be minimized where possible. Results: A sensitive liquid chromatography with tandem mass spectrometry (LC–MS/MS) method was validated and implemented across two phase III global pediatric trials. Two 10-μl aliquots of blood were collected at each time point using the Mitra®device. Concordance between plasma and dried blood was established from older pediatric patients. Incurred sample reanalysis was performed in both studies using the second Mitra tip and acceptance was greater than 83%. Conclusion: The use of microsampling to generate pharmacokinetic data in 2–18-year-old pediatric patients was successfully implemented. Positive feedback was received from clinical sites about the microsampling technique assisting with enrollment of pediatric patients.