Model-based clinical dose optimization for phenobarbital in neonates: An illustration of the importance of data sharing and external validation

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
Swantje VöllerDINO study group

Abstract

Particularly in the pediatric clinical pharmacology field, data-sharing offers the possibility of making the most of all available data. In this study, we utilize previously collected therapeutic drug monitoring (TDM) data of term and preterm newborns to develop a population pharmacokinetic model for phenobarbital. We externally validate the model using prospective phenobarbital data from an ongoing pharmacokinetic study in preterm neonates. TDM data from 53 neonates (gestational age (GA): 37 (24-42) weeks, bodyweight: 2.7 (0.45-4.5) kg; postnatal age (PNA): 4.5 (0-22) days) contained information on dosage histories, concentration and covariate data (including birth weight, actual weight, post-natal age (PNA), postmenstrual age, GA, sex, liver and kidney function, APGAR-score). Model development was carried out using NONMEM® 7.3. After assessment of model fit, the model was validated using data of 17 neonates included in the DINO (Drug dosage Improvement in NeOnates)-study. Modelling of 229 plasma concentrations, ranging from 3.2 to 75.2mg/L, resulted in a one compartment model for phenobarbital. Clearance (CL) and volume (Vd) for a child with a birthweight of 2.6kg at PNA day 4.5 was 0.0091L/h (9%) and 2.38L (5%), respectively...Continue Reading

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Citations

Jun 14, 2018·Epilepsia·Brady S MoffettSimon Y Kayyal
Feb 9, 2020·Pharmacy : Journal of Pharmacy, Education and Practice·Kate O'HaraJennifer J Schneider
Apr 7, 2020·British Journal of Clinical Pharmacology·Aline G J EngbersCatherijne A J Knibbe
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Oct 14, 2020·Expert Opinion on Drug Metabolism & Toxicology·Matthijs W van HoogdalemTomoyuki Mizuno
Oct 21, 2020·European Journal of Clinical Pharmacology·Janthima Methaneethorn, Nattawut Leelakanok
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Jul 10, 2021·CPT: Pharmacometrics & Systems Pharmacology·Jos LommerseJeffrey R Sachs
Jul 1, 2019·Neonatology·Laurent M A FaviéUNKNOWN on behalf of the PharmaCool study group

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