Evidence map›Paper›PMID 35370711›Full record

ArticleFrontiers in pharmacology2022

External Evaluation of Risperidone Population Pharmacokinetic Models Using Opportunistic Pediatric Data.

Eleni Karatza, Samit Ganguly, Chi D Hornik, William J Muller, Amira Al-Uzri, Laura James, Stephen J Balevic, Daniel Gonzalez

Registry-linked trialAbstract read
In one paragraph

Article in Frontiers in pharmacology, 2022. 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 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

8 authors.

Eleni KaratzaDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.
Samit GangulyDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.
Chi D HornikDuke Clinical Research Institute, Durham, NC, United States.
William J MullerAnn and Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, United States.
Amira Al-UzriOregon Health and Science University, Portland, OR, United States.
Laura JamesArkansas Children's Hospital Research Institute and the University of Arkansas for Medical Sciences, Little Rock, AR, United States.
Stephen J BalevicDuke Clinical Research Institute, Durham, NC, United States.
Daniel GonzalezDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.

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
NCATS NIH HHS UL1 TR002369
6 · The paper itself

Abstract

Risperidone is approved to treat schizophrenia in adolescents and autistic disorder and bipolar mania in children and adolescents. It is also used off-label in younger children for various psychiatric disorders. Several population pharmacokinetic models of risperidone and 9-OH-risperidone have been published. The objectives of this study were to assess whether opportunistically collected pediatric data can be used to evaluate risperidone population pharmacokinetic models externally and to identify a robust model for precision dosing in children. A total of 103 concentrations of risperidone and 112 concentrations of 9-OH-risperidone, collected from 62 pediatric patients (0.16-16.8 years of age), were used in the present study. The predictive performance of five published population pharmacokinetic models (four joint parent-metabolite models and one parent only) was assessed for accuracy and precision of the predictions using statistical criteria, goodness of fit plots, prediction-corrected visual predictive checks (pcVPCs), and normalized prediction distribution errors (NPDEs). The tested models produced similarly precise predictions (Root Mean Square Error [RMSE]) ranging from 0.021 to 0.027 nmol/ml for risperidone and 0.053-0.065 nmol/ml for 9-OH-risperidone). However, one of the models (a one-compartment mixture model with clearance estimated for three subpopulations) developed with a rich dataset presented fewer biases (Mean Percent Error [MPE, %] of 1.0%

Indexed as

pediatricspharmacokineticspopulation modelingprecision dosingrisperidone

Identifiers

PMID35370711
PMCPMC8969425

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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.