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

Managing blood volumes in pediatric studies is challenging and should be minimized where possible. 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...

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Bibliographic Details
Published in:Bioanalysis 2023-06, Vol.15 (11), p.621-636
Main Authors: Wickremsinhe, Enaksha R, Decker, Rodney L, Lee, Lisa B, Lelle, Erica, Carlton, Lena A, Keller, Stuart Y, Prakash, Apurva
Format: Article
Language:English
Subjects:
clinical sample analysis
concordance
dried blood
Mitra
pediatric trials
VAMs
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Summary:Managing blood volumes in pediatric studies is challenging and should be minimized where possible. 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%. 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.
ISSN:1757-6180
1757-6199
DOI:10.4155/bio-2023-0044