ArticleBritish journal of clinical pharmacology2021
Population pharmacokinetics of olanzapine in children.
Article in British journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01431326 (Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care), which is not on this map. Cited by 9 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Who cites it
9 citing papers in PubMed.
- Observational
- Application of a Stochastic Simulation-estimation Approach to Optimize Pharmacokinetic Study Design in the Context of Paediatric Extrapolation: A Tool to Support Decision-making by Drug Sponsors and Regulators.Pharmaceutical research · 2026Article
- Metabolic and Endocrine ADRs of Atypical Antipsychotics (AAPs) in Paediatric Patients with Autism Spectrum Disorder (ASD): A Review of Prevalence, Risk Factors, and Implications for Clinical Monitoring.Journal of clinical medicine · 2025Review
- Population Pharmacokinetics of Alfentanil in Children.Journal of clinical pharmacology · 2025Article
- Intranasal diamorphine population pharmacokinetics modeling and simulation in pediatric breakthrough pain.CPT: pharmacometrics & systems pharmacology · 2025Article
- Delayed-Onset olanzapine-induced rhabdomyolysis.BMJ case reports · 2023Article
- Olanzapine Pharmacokinetics: A Clinical Review of Current Insights and Remaining Questions.Pharmacogenomics and personalized medicine · 2023Review
- Gluteal muscle damage and rhabdomyolysis after olanzapine poisoning: a case report.The Journal of international medical research · 2021Article
- What to Do About Missed Doses? A Retrospective Study of Olanzapine in the Elderly.Drug design, development and therapy · 2021Article
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Authors and funding
13 authors.
Funding
Abstract
aimsThe aim of this study was to evaluate the population pharmacokinetics (PopPK) of olanzapine in children and devise a model-informed paediatric dosing scheme.
methodsThe PopPK of olanzapine was characterized using opportunistically collected plasma samples from children receiving olanzapine per standard of care for any indication. A nonlinear mixed effect modelling approach was employed for model development using the software NONMEM (v7.4). Simulations from the developed PopPK model were used to devise a paediatric dosing scheme that targeted comparable plasma exposures to adolescents and adults.
resultsForty-five participants contributed 83 plasma samples towards the analysis. The median (range) postnatal age and body weight of participants were 3.8 years (0.2-19.2) and 14.1 kg (4.2-111.7), respectively. The analysis was restricted to pharmacokinetic (PK) samples collected following enteral administration (oral and feeding tube). A one-compartment model with linear elimination provided an appropriate fit to the data. The final model included the covariates body weight and postmenstrual age (PMA) on apparent olanzapine clearance (CL/F). Typical CL/F and apparent volume of distribution (scaled to 70 kg) were 16.8 L/h (21% RSE) and 663 L (13% RSE), respectively. Developed dosing schemes used weight-normalized doses for children ≤6 months postnatal age or <15 kg and fixed doses for children ≥15 kg.
conclusionWe developed a paediatric PopPK model for enterally-administered olanzapine. To our knowledge, this analysis is the first study to characterize the PK of olanzapine in participants ranging from infants to adolescents. Body weight and PMA were identified as influential covariates for characterizing developmental changes in olanzapine apparent clearance.
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