ArticleTherapeutic drug monitoring2014
Predictive performance of a gentamicin population pharmacokinetic model in neonates receiving full-body hypothermia.
Article in Therapeutic drug monitoring, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed.
- The Effect of Inflammatory Bowel Disease and Irritable Bowel Syndrome on Pravastatin Oral Bioavailability: In vivo and in silico evaluation using bottom-up wbPBPK modeling.AAPS PharmSciTech · 2024Article
- Evaluating the Pharmacokinetics of Fentanyl in the Brain Extracellular Fluid, Saliva, Urine, and Plasma of Newborns from Transplacental Exposure from Parturient Mothers Dosed with Epidural Fentanyl Utilizing PBPK Modeling.European journal of drug metabolism and pharmacokinetics · 2023Article
- The Analysis of Pethidine Pharmacokinetics in Newborn Saliva, Plasma, and Brain Extracellular Fluid After Prenatal Intrauterine Exposure from Pregnant Mothers Receiving Intramuscular Dose Using PBPK Modeling.European journal of drug metabolism and pharmacokinetics · 2023Article
- Enhancing Atorvastatin In Vivo Oral Bioavailability in the Presence of Inflammatory Bowel Disease and Irritable Bowel Syndrome Using Supercritical Fluid Technology Guided by wbPBPK Modeling in Rat and Human.AAPS PharmSciTech · 2022Article
- Can Population Pharmacokinetics of Antibiotics be Extrapolated? Implications of External Evaluations.Clinical pharmacokinetics · 2021Review
- Simplified Dosing Regimens for Gentamicin in Neonatal Sepsis.Frontiers in pharmacology · 2021Article
- Infection control and other stewardship strategies in late onset sepsis, necrotizing enterocolitis, and localized infection in the neonatal intensive care unit.Seminars in perinatology · 2020Article
- Renal Clearance in Newborns and Infants: Predictive Performance of Population-Based Modeling for Drug Development.Clinical pharmacology and therapeutics · 2019Observational
- Vancomycin in Pediatric Patients with Solid or Hematological Malignant Disease: Predictive Performance of a Population Pharmacokinetic Model and New Optimized Dosing Regimens.Paediatric drugs · 2018Article
- Dosing antibiotics in neonates: review of the pharmacokinetic data.Future microbiology · 2017Article
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8 authors.
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Abstract
backgroundPopulation pharmacokinetic (popPK) models derived from small pharmacokinetics (PK) studies in neonates are often underpowered to detect clinically important characteristics that drive dosing. External validation of such models is crucial. In this study, the predictive performance of a gentamicin popPK model in neonates receiving hypothermia was evaluated.
methodsA previously published gentamicin popPK model was developed in neonates with hypoxic ischemic encephalopathy undergoing hypothermia using a retrospective single-institution (University of California-San Francisco) data set. The predictive performance of this model was evaluated in an external retrospective data set from the University of California-San Francisco (validation A) and another from Duke University (validation B). Both institutions used the same hypothermia protocol and collected similar clinical and PK data. Gentamicin dosing and samples were collected per routine care. Predictive performance was evaluated by quantifying the accuracy and precision of model predictions and using simulation-based diagnostics to detect bias in predictions.
resultsForty-one neonates (n = 18 validation A; n = 23 validation B) with median (range) gestational age of 40 weeks (33-42) and birth weight of 3.3 kg (1.9-4.6) and 76 samples (55% troughs, 33% and 28% drawn at 24 and 36 hours after dose, respectively) were analyzed. The model adequately predicted gentamicin concentrations from the same institution (validation A; median average fold error = 1.1 and numerical prediction distribution error P > 0.05) but underpredicted concentrations from the outside institution (validation B; median average fold error = 0.6 and numerical prediction distribution error P < 0.05).
conclusionsThe model demonstrated adequate predictive performance for an external data set in the same institution but not from an outside institution. Larger sample sizes, use of data from multiple institutions, and external evaluation in development of popPK models in neonates may improve generalizability of dosing recommendations arising from single-institution studies.
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