Paul Abu-Rabie1, Bikalpa Neupane2, Neil Spooner3, James Rudge4, Philip Denniff5, Hussain Mulla6, Hitesh Pandya2. 1. Medicinal Science & Technology, GlaxoSmithKline R&D, Stevenage, UK. 2. Department of Respiratory Sciences, College of Life Sciences, University of Leicester, Leicester, UK. 3. Spooner Bioanalytical Solutions Ltd, Hertford, UK & School of Life & Medical Sciences University of Hertfordshire, Hertfordshire, UK. 4. Neoteryx, Torrance, CA, USA. 5. Drug Metabolism & Pharmacokinetics, GlaxoSmithKline R&D, Ware, UK (Retired). 6. Department of Pharmacy, University Hospitals of Leicester, Leicester, UK.
Abstract
Aim: Collection and quantitative analysis in dry blood using volumetric absorptive microsampling (VAMS™) potentially offers significant advantages over conventional wet whole blood analysis. This manuscript explores their use for pediatric sampling and explores additional considerations for the validation of the bioanalytical method. Results: HPLC-MS/MS methods for the determination of midazolam and its major metabolite 1-OH midazolam in both whole wet blood, and dry blood collected on VAMS were developed, validated, and used to support an observational clinical study to compare pharmacokinetic parameters in pediatric patients. Conclusion: Validation data met internationally accepted guideline criteria. A strong correlation was observed in calculated concentrations between wet and dry test samples, indicating that VAMS is a suitable technique for use in pediatric clinical studies.
Aim: Collection and quantitative analysis in dry blood using volumetric absorptive microsampling (VAMS™) potentially offers significant advantages over conventional wet whole blood analysis. This manuscript explores their use for pediatric sampling and explores additional considerations for the validation of the bioanalytical method. Results: HPLC-MS/MS methods for the determination of midazolam and its major metabolite 1-OH midazolam in both whole wet blood, and dry blood collected on VAMS were developed, validated, and used to support an observational clinical study to compare pharmacokinetic parameters in pediatric patients. Conclusion: Validation data met internationally accepted guideline criteria. A strong correlation was observed in calculated concentrations between wet and dry test samples, indicating that VAMS is a suitable technique for use in pediatric clinical studies.
Authors: Domenico Umberto De Rose; Sara Cairoli; Marco Dionisi; Alessandra Santisi; Luca Massenzi; Bianca Maria Goffredo; Carlo Dionisi-Vici; Andrea Dotta; Cinzia Auriti Journal: Int J Mol Sci Date: 2020-08-17 Impact factor: 5.923