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 Mitratip and acceptance was greater than 83%. Conclusion: The use of microsampling to generate pharmacokineticdata in 2-18-year-old pediatric patients was successfully implemented. Positive feedback was received from clinical sites about the microsampling technique assistingwith enrollment of pediatric patients.
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