Evidence map›Paper›PMID 26060393›Full record

ArticleDrug design, development and therapy2015

Population pharmacokinetics of methylphenidate hydrochloride extended-release multiple-layer beads in pediatric subjects with attention deficit hyperactivity disorder.

Nathan S Teuscher, Akwete Adjei, Robert L Findling, Laurence L Greenhill, Robert J Kupper, Sharon Wigal

Open access · goldAbstract read
In one paragraph

Article in Drug design, development and therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.5field-weighted citation impact, top 19% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. New Formulations of Stimulants: An Update for Clinicians.Journal of child and adolescent psychopharmacology · 2019
    Review
  6. ADHD in children and youth: Part 2-Treatment.Paediatrics & child health · 2018
    Review
  7. 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

6 authors at 3 institutions in 1 country.

Nathan S TeuscherPK/PD Associates, Trophy Club, TX, USA.
Akwete AdjeiRhodes Pharmaceuticals L.P., Coventry, RI, USA.
Robert L FindlingDepartment of Psychiatric Services and Research, Kennedy Krieger Institute, Baltimore, MD, USA ; Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA.
Laurence L GreenhillDepartment of Psychiatry, Division of Child and Adolescent Psychiatry, New York State Psychiatric Institute, Columbia University, New York, NY, USA.
Robert J KupperRhodes Pharmaceuticals L.P., Coventry, RI, USA.
Sharon WigalAVIDA Inc., Newport Beach, CA, USA.
Kennedy Krieger Institute · USNew York Psychoanalytic Society and Institute · USScience Club · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A new multilayer-bead formulation of extended-release methylphenidate hydrochloride (MPH-MLR) has been evaluated in pharmacokinetic studies in healthy adults and in Phase III efficacy/safety studies in children and adolescents with attention deficit hyperactivity disorder (ADHD). Using available data in healthy adults, a two-input, one-compartment, first-order elimination population pharmacokinetic model was developed using nonlinear mixed-effect modeling. The model was then extended to pediatric subjects, and was found to adequately describe plasma concentration-time data for this population. A pharmacokinetic/pharmacodynamic model was also developed using change from baseline in the ADHD Rating Scale (ADHD-RS)-IV total scores from a pediatric Phase III trial and simulated plasma concentration-time data. During simulations for each MPH-MLR dose level (10-80 mg), increased body weight resulted in decreased maximum concentration. Additionally, as maximum concentration increased, ADHD-RS-IV total score improved (decreased). Knowledge of the relationship between dose, body weight, and clinical response following the administration of MPH-MLR in children and adolescents may be useful for clinicians selecting initial dosing of MPH-MLR. Additional study is needed to confirm these results.

Indexed as

Models, BiologicalAdolescentAdultAge FactorsAttention Deficit Disorder with HyperactivityCentral Nervous System StimulantsChemistry, PharmaceuticalChildDelayed-Action PreparationsDose-Response Relationship, DrugHumansMethylphenidateNonlinear DynamicsCentral Nervous System StimulantsDelayed-Action PreparationsMethylphenidateAptensio XR™methylphenidateMPH-MLRpopulation pharmacokinetics

Identifiers

PMID26060393
PMCPMC4454220
OpenAlexW1708624782

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.