Evidence map›Paper›PMID 22270322›Full record

SynthesisJournal of pharmacokinetics and pharmacodynamics2012

Population pharmacodynamic modeling of various extended-release formulations of methylphenidate in children with attention deficit hyperactivity disorder via meta-analysis.

Holly Kimko, Ekaterina Gibiansky, Leonid Gibiansky, H Lynn Starr, Joris Berwaerts, Joseph Massarella, Frank Wiegand

Abstract readComparative StudyMeta-Analysis
PubMed Publisher
In one paragraph

Synthesis in Journal of pharmacokinetics and pharmacodynamics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
–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.

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

17 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  14. Utilization of model-based meta-analysis to delineate the net efficacy of taspoglutide from the response of placebo in clinical trials.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2015
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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

7 authors.

Holly KimkoAdvanced Modeling & Simulation, Janssen Research & Development, LLC, 920 Route 202, Raritan, NJ 08869, USA. HKimko@its.jnj.com
Ekaterina Gibiansky
Leonid Gibiansky
H Lynn Starr
Joris Berwaerts
Joseph Massarella
Frank Wiegand

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Placebo and pharmacodynamic (PD) models were developed which link temporal measures of efficacy in children with attention deficit hyperactivity disorder (ADHD) and methylphenidate (MPH) plasma concentrations from adults. These models can be used to predict daily pediatric clinical measure profiles following administration of different MPH formulations in children without conducting pediatric pharmacokinetic (PK) or PD studies by using more easily obtained adult PK data. Mean PK data from various extended-release MPH formulations studied in adults and mean PD data from nine pediatric efficacy studies were obtained from the literature. The individual time-course of the clinical measures from three pediatric trials were also analyzed after being combined with the meta-analysis data. The clinical measure profiles following placebo administration were described by indirect response models with time-varying elimination rates. MPH pharmacodynamic effect was described by E(max) models, which included time-dependent tolerance. Internal and external evaluations using a visual predictive check technique confirmed the prediction capability of the models. This modeling exercise demonstrated that time courses of MPH concentrations in adults with different drug release patterns can be used to predict time courses of clinical efficacy parameters in pediatrics by employing the models developed by meta-analysis.

Indexed as

Models, BiologicalAttention Deficit Disorder with HyperactivityChildDelayed-Action PreparationsFemaleHumansMaleMethylphenidateRandomized Controlled Trials as TopicDelayed-Action PreparationsMethylphenidate

Identifiers

What OpenQuestion holds

Textmetadata
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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.