Evidence map›Paper›PMID 38566433›Full record

ReviewCPT: pharmacometrics & systems pharmacology2024

Covariate modeling in pharmacometrics: General points for consideration.

Kinjal Sanghavi, Jakob Ribbing, James A Rogers, Mariam A Ahmed, Mats O Karlsson, Nick Holford, Estelle Chasseloup, Malidi Ahamadi, Kenneth G Kowalski, Susan Cole and 8 more

Abstract readReview
In one paragraph

Review in CPT: pharmacometrics & systems pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 3 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

32 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  9. SCOUT: An Exploratory Approach to Scouting Dose-Relevant Covariates.CPT: pharmacometrics & systems pharmacology · 2026
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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

18 authors.

Kinjal SanghaviClinical Pharmacology, Genmab US, Inc., Princeton, New Jersey, USA.
Jakob RibbingPharmetheus AB, Uppsala, Sweden.
James A RogersMetrum Research Group, Tariffville, Connecticut, USA.ORCID 0009-0004-2363-1339
Mariam A AhmedQuantitative Clinical Pharmacology, Takeda Pharmaceutical, Cambridge, Massachusetts, USA.ORCID 0000-0002-1229-7353
Mats O KarlssonDepartment of Pharmacy, Uppsala University, Uppsala, Sweden.ORCID 0000-0003-1258-8297
Nick HolfordDepartment of Pharmacology & Clinical Pharmacology, University of Auckland, Auckland, New Zealand.ORCID 0000-0002-4031-2514
Estelle ChasseloupDepartment of Pharmacy, Uppsala University, Uppsala, Sweden.
Malidi AhamadiModeling and Simulation, Sanofi, Bridgewater, Sanofi, USA.
Kenneth G KowalskiPMetrics Consulting, Northville, Michigan, USA.
Susan ColeMedical and Healthcare product Regulatory Agency (MHRA), London, UK.
Essam KerwashMedical and Healthcare product Regulatory Agency (MHRA), London, UK.ORCID 0000-0003-4368-8565
Janet R WadeOccams, Amstelveen, The Netherlands.
Chao LiuApplied Innovation Quantitative Solutions, BeiGene, Washington, DC, USA.
Yaning WangCreaterna Science and Technology, Clarksburg, Maryland, USA.
Mirjam N TrameIntegrated Drug Development Northeast Regional Lead, Certara, Massachusetts, USA.
Hao ZhuDivision of Pharmacometrics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Springs, Maryland, USA.
Justin J WilkinsOccams, Amstelveen, The Netherlands.ORCID 0000-0002-7099-9396
ISoP Standards & Best Practices Committee

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Modeling the relationships between covariates and pharmacometric model parameters is a central feature of pharmacometric analyses. The information obtained from covariate modeling may be used for dose selection, dose individualization, or the planning of clinical studies in different population subgroups. The pharmacometric literature has amassed a diverse, complex, and evolving collection of methodologies and interpretive guidance related to covariate modeling. With the number and complexity of technologies increasing, a need for an overview of the state of the art has emerged. In this article the International Society of Pharmacometrics (ISoP) Standards and Best Practices Committee presents perspectives on best practices for planning, executing, reporting, and interpreting covariate analyses to guide pharmacometrics decision making in academic, industry, and regulatory settings.

Indexed as

Models, StatisticalHumansModels, Biological

Identifiers

PMID38566433
PMCPMC11098153

What OpenQuestion holds

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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.