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Validation of methods for determining pediatric midazolam using wet whole blood and volumetric absorptive microsampling.

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.

Authors+Show Affiliations

Medicinal Science & Technology, GlaxoSmithKline R&D, Stevenage, UK.Department of Respiratory Sciences, College of Life Sciences, University of Leicester, Leicester, UK.Spooner Bioanalytical Solutions Ltd, Hertford, UK & School of Life & Medical Sciences University of Hertfordshire, Hertfordshire, UK.Neoteryx, Torrance, CA, USA.Drug Metabolism & Pharmacokinetics, GlaxoSmithKline R&D, Ware, UK (Retired).Department of Pharmacy, University Hospitals of Leicester, Leicester, UK.Department of Respiratory Sciences, College of Life Sciences, University of Leicester, Leicester, UK.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31617393

Citation

Abu-Rabie, Paul, et al. "Validation of Methods for Determining Pediatric Midazolam Using Wet Whole Blood and Volumetric Absorptive Microsampling." Bioanalysis, 2019.
Abu-Rabie P, Neupane B, Spooner N, et al. Validation of methods for determining pediatric midazolam using wet whole blood and volumetric absorptive microsampling. Bioanalysis. 2019.
Abu-Rabie, P., Neupane, B., Spooner, N., Rudge, J., Denniff, P., Mulla, H., & Pandya, H. (2019). Validation of methods for determining pediatric midazolam using wet whole blood and volumetric absorptive microsampling. Bioanalysis, doi:10.4155/bio-2019-0190.
Abu-Rabie P, et al. Validation of Methods for Determining Pediatric Midazolam Using Wet Whole Blood and Volumetric Absorptive Microsampling. Bioanalysis. 2019 Oct 16; PubMed PMID: 31617393.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Validation of methods for determining pediatric midazolam using wet whole blood and volumetric absorptive microsampling. AU - Abu-Rabie,Paul, AU - Neupane,Bikalpa, AU - Spooner,Neil, AU - Rudge,James, AU - Denniff,Philip, AU - Mulla,Hussain, AU - Pandya,Hitesh, Y1 - 2019/10/16/ PY - 2019/10/17/entrez KW - LC–MS KW - Mitra® microsamplers KW - blood KW - hematocrit KW - microsampling KW - pediatric KW - pharmacokinetics KW - volumetric absorptive sampling (VAMS) KW - wet vs dry JF - Bioanalysis JO - Bioanalysis N2 - 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. SN - 1757-6199 UR - https://www.unboundmedicine.com/medline/citation/31617393/Validation_of_methods_for_determining_pediatric_midazolam_using_wet_whole_blood_and_volumetric_absorptive_microsampling L2 - https://www.future-science.com/doi/full/10.4155/bio-2019-0190?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -