Author: Jeannine Sato

Physiologically Based Pharmacokinetic Modeling of Oxcarbazepine to Characterize Its Disposition in Children with Obesity

Posted on by Jeannine Sato

Journal of Clinical Pharmacology • September 2025

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Maglalang PD, Sinha J, Helfer VE, Edginton A, Zimmerman K, Hornik CD, Muller WJ, Rathore M, Benjamin DK Jr, Chen JY, Anand R, Gonzalez D; Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee. 

Oxcarbazepine (OXC) is a second-generation antiseizure medication, effective through its active metabolite, 10-mono-hydroxy derivative (MHD). OXC is used as adjunctive therapy for focal-onset and primary generalized tonic-clonic seizures, with recommended dosing based on age and body weight. This study uses physiologically based pharmacokinetic (PBPK) modeling and leverages pharmacokinetic (PK) data acquired from children enrolled in pragmatic trials to understand dosing and subsequent exposure requirements in children with obesity. 

Physiologically Based and Population Pharmacokinetic Modeling of Midazolam in Children With Obesity Using Real-World Data

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Clinical and Translational Science • May 2025

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McCann S, Helfer VE, Balevic SJ, Muller WJ, van den Anker JN, Al-Uzri A, Meyer ML, Anderson SG, Turdalieva S, Edginton AN, Gonzalez D; Best Pharmaceuticals for Children Act Pediatric Trials Network Steering Committee.

Midazolam has been used as a sedative for hospitalized children on- and off-label; however, factors affecting interindividual variability (IIV) in observed clearance for this population are not fully understood and can result in extreme under- or overexposure. Obesity has been described as a significant influence on midazolam in adolescents, which could potentially alter drug exposure. The goal of this study was to use two modeling strategies to evaluate dose-exposure of midazolam in children with and without obesity. 

Expansion of a Pharmacokinetic Model for Diazepam to Characterize Real-World IV and Oral Data in Children With and Without Obesity

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Journal of Clinical Pharmacology • April 2025

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McCann SM, Wen J, Balevic SJ, Muller WJ, Al-Uzri A, Hornik CD, Meyer ML, Anderson SG, Payne EH, Turdalieva S, Chamberlain JM, Gonzalez D; Best Pharmaceuticals for Children Act Pediatric Trials Network Steering Committee.

Diazepam is a benzodiazepine approved for use in adults and children. The label incorporates recommended dosing for status epilepticus in children. Published population pharmacokinetic (PK) modeling recommends an intravenous bolus dose of 0.2 mg/kg capped at 8 mg to reach the suggested target exposure of 200-600 ng/mL at 10 min post dose in children up to 17 years of age. This model was developed for children generally without obesity based on IV data, and it is unclear how increased body weight may affect exposure or target attainment given capped dosing.

Furosemide Safety in Preterm Infants at Risk for Bronchopulmonary Dysplasia: A Randomized Clinical Trial

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The Journal of Pediatrics • April 2025

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Greenberg RG, Lang J, Smith PB, Shekhawat P, Courtney SE, Hudak ML, Moya F, Iyengar A, Eldemerdash A, Bloom B, Go M, Hanna M, Rhein L, Aliaga S, Lewis T, Febre A, Kiefer AS, Bhatt-Mehta V, Khoury JA, Selewski D, Anand R, Martz K, Payne EH, Zimmerman KO, Benjamin DK Jr, Laughon M; Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee.

The objective of this study was to evaluate the safety of furosemide in preterm infants at the risk of developing bronchopulmonary dysplasia (BPD). This multicenter, randomized, dose-escalating, placebo-controlled trial enrolled infants born <29 weeks gestational age at 7-28 days postnatal age and at risk for BPD. In preterm infants, furosemide did not increase the overall incidence of AEs, hearing loss, or nephrocalcinosis, but did increase the incidence of electrolyte abnormalities. Furosemide given for 28 consecutive days was not associated with a difference in moderate-to-severe BPD or death at 36 weeks postmenstrual age.

Medical treatment of gastroesophageal reflux in the neonatal intensive care unit: current practice

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Journal of Perinatology, February 2025

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Lockyear C, Stark A, Foote HP, Agyeman A, Bouleqcha M, Cohen N, Matusevich C, Pantsari A, Wang S, Rent S, Malcolm W, Tolia VN, Greenberg RG, Aleem S.

The objective of this study was to determine current prescribing practice of acid-suppressive therapy in preterm infants admitted to the neonatal intensive care unit (NICU). A cohort study of infants 22 to 27 weeks gestation were discharged from Pediatrix Medical Group NICUs between 2015 and 2020. The study showed that acid-suppressive therapies are used commonly in preterm infants and receipt is higher in infants with lower BWs. Use has significantly decreased over time and appears to be targeted, with many infants treated for one-week courses and without a diagnosis of GERD.