Evidence map›Paper›PMID 34289143›Full record

ArticleBritish journal of clinical pharmacology2022

Comparison between physiologically based pharmacokinetic and population pharmacokinetic modelling to select paediatric doses of gepotidacin in plague.

Dung Nguyen, Jafar Sadik Shaik, Guoying Tai, Courtney Tiffany, Caroline Perry, Etienne Dumont, David Gardiner, Aline Barth, Rajendra Singh, Mohammad Hossain

Open access · hybridAbstract read
In one paragraph

Article in British journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.9field-weighted citation impact, top 27% 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

8 citing papers in PubMed, 11 citations in OpenAlex.

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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

10 authors at 1 institution in 1 country.

Dung NguyenGlaxoSmithKline, Collegeville, PA, United States.
Jafar Sadik ShaikGlaxoSmithKline, Collegeville, PA, United States.
Guoying TaiGlaxoSmithKline, Collegeville, PA, United States.
Courtney TiffanyGlaxoSmithKline, Collegeville, PA, United States.
Caroline PerryGlaxoSmithKline, Collegeville, PA, United States.
Etienne DumontGlaxoSmithKline, Collegeville, PA, United States.
David GardinerGlaxoSmithKline, Collegeville, PA, United States.
Aline BarthGlaxoSmithKline, Collegeville, PA, United States.
Rajendra SinghGlaxoSmithKline, Collegeville, PA, United States.
Mohammad HossainGlaxoSmithKline, Collegeville, PA, United States.
GlaxoSmithKline (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo develop physiologically based pharmacokinetic (PBPK) and population pharmacokinetic (PopPK) models to predict effective doses of gepotidacin in paediatrics for the treatment of pneumonic plague (Yersinia pestis).

methodsA gepotidacin PBPK model was constructed using a population-based absorption, distribution, metabolism and excretion simulator, Simcyp®, with physicochemical and in vitro data, optimized with clinical data from a dose-escalation intravenous (IV) study and a human mass balance study. A PopPK model was developed with pooled PK data from phase 1 studies with IV gepotidacin in healthy adults.

resultsFor both the PopPK and PBPK models, body weight was found to be a key covariate affecting gepotidacin clearance. With PBPK, ~90% of the predicted PK for paediatrics fell between the 5th and 95th percentiles of adult values except for subjects weighing ≤5 kg. PopPK-simulated paediatric means for C

conclusionsBoth PBPK and PopPK approaches can reasonably predict gepotidacin exposures in children.

Indexed as

PlagueAcenaphthenesAdministration, IntravenousChildComputer SimulationHeterocyclic Compounds, 3-RingHumansInfantModels, BiologicalAcenaphthenesgepotidacinHeterocyclic Compounds, 3-RingmodellingPBPKpharmacodynamicspopulation analysissimulation

Identifiers

PMID34289143
PMCPMC9293063
OpenAlexW3185567167

What OpenQuestion holds

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LicenceCC BY-NC
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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.