POP01

Population Pharmacokinetics and Dosing Simulations of Pentobarbital in the Pediatric Population

Posted on by Jeannine Sato

Journal of Clinical Pharmacology • May 2026

Access article on PubMed.

Helfer VE, Medina-Aymerich L, Muller WJ, Meyer M, Al-Uzri A, McCulloh R, Hornik CD, Balevic SJ, Greenberg RG, Benjamin DK Jr, Anderson SG, Gonzalez D; Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee.

Pentobarbital is a barbiturate with sedative and anticonvulsant properties, occasionally used in pediatric patients for preoperative sedation, deep sedation during mechanical ventilation, and seizure control. Despite its long-standing clinical use, age-appropriate dosing remains challenging due to variability across studies and limited pediatric pharmacokinetic (PK) data. This study (NCT01431326) aimed to characterize the population pharmacokinetics of pentobarbital in pediatric patients (birth to 21 years) and evaluate dosing strategies using model-based simulations.

Population Pharmacokinetics and Exposure-Safety Analysis of Furosemide in Preterm Infants

Posted on by Jeannine Sato

Journal of Clinical Pharmacology • April 2026

Access article on PubMed.

Randell RL, Maharaj A, Laughon M, Hornik CD, Greenberg RG, Lang JE, Cohen-Wolkowiez M, Hornik CP, Anand R, Martz K, Payne EH, Watt K, Muller WJ, Courtney SE, Atz A, Al-Uzri A, Sokol GM, Bloom BT, Iyengar A, Hanna M, Benjamin DK Jr, Balevic SJ; Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee.

Furosemide is the most commonly used diuretic in preterm infants despite an incompletely understood relationship between dosing, exposure, and safety within this population. The goals of this study were to characterize furosemide population pharmacokinetics (popPK) in preterm infants and to evaluate safety by relating simulated furosemide exposure to events of ototoxicity, nephrocalcinosis, and nephrolithiasis. A total of 146 plasma furosemide concentrations from 51 preterm (23-28.9 weeks’ gestational age) infants across two studies (one randomized, placebo-controlled, dose-escalating safety trial and one opportunistic, observational study) were included in the analysis. Standard nonlinear mixed effects popPK modeling techniques were applied.