Evidence map›Paper›PMID 32497307›Full record

ArticleBritish journal of clinical pharmacology2021

Population pharmacokinetics of olanzapine in children.

Anil R Maharaj, Huali Wu, Kanecia O Zimmerman, Julie Autmizguine, Rohit Kalra, Amira Al-Uzri, Catherine M T Sherwin, Stuart L Goldstein, Kevin Watt, Jinson Erinjeri and 3 more

Registry-linked trialAbstract read
In one paragraph

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.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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.

NCT01431326 completednot on this map

Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

TypeobservationalSponsorDaniel BenjaminRan2011 to 2019Enrolled3,520ConditionsAdenovirus, Anesthesia, Anxiety, AnxiolysisArmsThe POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Observational
  2. Article
  3. Review
  4. Population Pharmacokinetics of Alfentanil in Children.Journal of clinical pharmacology · 2025
    Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Anil R MaharajDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Huali WuDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Kanecia O ZimmermanDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Julie AutmizguineDepartment of Pediatrics, CHU Sainte-Justine, Montreal, Canada.
Rohit KalraAnn & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.
Amira Al-UzriOregon Health and Science University, Portland, OR, USA.
Catherine M T SherwinDepartment of Pharmacotherapy, College of Pharmacy, University of Utah, Salt Lake City, UT, USA.ORCID 0000-0002-0844-3207
Stuart L GoldsteinDepartment of Pediatrics, University of Cincinnati, Cincinnati, OH, USA.
Kevin WattDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.ORCID 0000-0002-5975-5091
Jinson ErinjeriThe Emmes Company, LLC, Rockville, MD, USA.
Elizabeth H PayneThe Emmes Company, LLC, Rockville, MD, USA.
Michael Cohen-WolkowiezDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Christoph P HornikDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.ORCID 0000-0001-7056-8759

Funding

Oregon Clinical and Translational Research Institute - The National COVID Cohort Collaborative (N3C)UL1TR002369 · NCATS · OREGON HEALTH & SCIENCE UNIVERSITY · PI Cynthia D Morris, Christopher G. Slatore · 2017 to 2026
$78.4M
Utah Center for Clinical and Translational ScienceUL1TR002538 · NCATS · UNIVERSITY OF UTAH · PI HESS, RACHEL, MAJERSIK, JENNIFER JUHL · 2018 to 2022
$26.0M
Duke CTSA (Composite)KL2TR001115 · NCATS · DUKE UNIVERSITY · PI BOULWARE, LEIGH E, KRAFT, MONICA · 2013 to 2017
$5.1M
Physiologically-Based Pharmacokinetic Approach to Determine Dosing on Extracorporeal Life SupportR01HD097775 · NICHD · UNIVERSITY OF UTAH · PI WATT, KEVIN M · 2019 to 2023
$2.7M
Pharmacokinetics, Pharmacodynamics, and Safety of Methylprednisolone in Neonates on Cardiopulmonary BypassK23HD090239 · NICHD · DUKE UNIVERSITY · PI HORNIK, CHRISTOPH · 2017 to 2020
$646k
Investigating polypharmacy-related adverse events in critically ill children using electronic health records and simulated drug levelsK23HD091398 · NICHD · DUKE UNIVERSITY · PI ZIMMERMAN, KANECIA OBIE · 2017 to 2020
$629k
NCATS NIH HHS KL2 TR001115NCATS NIH HHS UL1 TR002369NCATS NIH HHS UL1 TR002538NICHD NIH HHS HHSN267200700051CNICHD NIH HHS HHSN275201000003CNICHD NIH HHS HHSN275201000003INICHD NIH HHS K23 HD090239NICHD NIH HHS K23 HD091398NICHD NIH HHS R01 HD097775
6 · The paper itself

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.

Indexed as

Models, BiologicalNonlinear DynamicsAdolescentAdultChildHumansInfantOlanzapineOlanzapinechildrendosingolanzapinepaediatricpopulation pharmacokinetics

Identifiers

PMID32497307
PMCPMC9008710

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.