Evidence map›Paper›PMID 40347307›Full record

ArticleJournal of pharmacokinetics and pharmacodynamics2025

Beyond the linear model in concentration-QT analysis.

Géraldine Cellière, Andreas Krause, Guillaume Bonnefois, Jonathan Chauvin

Abstract read
In one paragraph

Article in Journal of pharmacokinetics and pharmacodynamics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

4 authors.

Géraldine CellièreClinical Pharmacology and Pharmacometrics, Simulations Plus, Inc., PO Box 12317, Research Triangle Park, NC, 27709, USA. geraldine.celliere@simulations-plus.com.ORCID 0009-0009-6904-5569
Andreas KrauseClinical Pharmacology and Pharmacometrics, Simulations Plus, Inc., PO Box 12317, Research Triangle Park, NC, 27709, USA.ORCID 0000-0002-4686-976X
Guillaume BonnefoisClinical Pharmacology and Pharmacometrics, Simulations Plus, Inc., PO Box 12317, Research Triangle Park, NC, 27709, USA.ORCID 0000-0002-5769-8855
Jonathan ChauvinClinical Pharmacology and Pharmacometrics, Simulations Plus, Inc., PO Box 12317, Research Triangle Park, NC, 27709, USA.ORCID 0009-0007-1655-1113

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The white-paper regression model is the standard method for assessing QT liability of drugs. The quantity of interest, placebo-corrected QTc change from baseline (ΔΔQTc) with corresponding confidence interval (CI), is derived from the difference in model-estimated ΔQTc for active compound and placebo in a linear model. Model assumptions include linearity and no time delay between change in concentration and change in ΔQTc. Alternative models are commonly not considered unless there is a clear indication of inappropriateness of the assumptions. This work introduces several extensions for concentration-QT modeling in a pharmacometric context. The model is formulated as linear drug-effect model with treatment, nominal time, and centered baseline as covariates on the intercept. This approach enables straightforward use of other concentration-ΔQTc relationships, including loglinear, E

Indexed as

Long QT SyndromeModels, BiologicalBayes TheoremElectrocardiographyHumansLinear ModelsNonlinear DynamicsConcentration-QTHysteresisPopulation PK/PDQT intervalTQT

Identifiers

PMID40347307
PMCPMC12065759

What OpenQuestion holds

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Registered trials

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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.