Evidence map›Paper›PMID 27566992›Full record

ArticleCPT: pharmacometrics & systems pharmacology2016

Predictive Performance of Physiologically Based Pharmacokinetic and Population Pharmacokinetic Modeling of Renally Cleared Drugs in Children.

W Zhou, T N Johnson, H Xu, Sya Cheung, K H Bui, J Li, N Al-Huniti, D Zhou

Open access · goldAbstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed
13.1field-weighted citation impact, top 2% 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

49 citing papers in PubMed, 84 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

8 authors at 3 institutions in 2 countries.

W ZhouQuantitative Clinical Pharmacology, AstraZeneca, Waltham, Massachusetts, USA.
T N JohnsonSimcyp (A Certara Company), Sheffield, United Kingdom.
H XuQuantitative Clinical Pharmacology, AstraZeneca, Waltham, Massachusetts, USA.
Sya CheungQuantitative Clinical Pharmacology, AstraZeneca, Cambridge, United Kingdom.
K H BuiQuantitative Clinical Pharmacology, AstraZeneca, Waltham, Massachusetts, USA.
J LiQuantitative Clinical Pharmacology, AstraZeneca, Waltham, Massachusetts, USA.
N Al-HunitiQuantitative Clinical Pharmacology, AstraZeneca, Waltham, Massachusetts, USA.
D ZhouQuantitative Clinical Pharmacology, AstraZeneca, Waltham, Massachusetts, USA. Diansong.Zhou@astrazeneca.com.
AstraZeneca (United States) · USAstraZeneca (United Kingdom) · GBSimcyp (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Predictive performance of physiologically based pharmacokinetic (PBPK) and population pharmacokinetic (PopPK) models of drugs predominantly eliminated through kidney in the pediatric population was evaluated. After optimization using adult clinical data, the verified PBPK models can predict 33 of 34 drug clearance within twofold of the observed values in children 1 month and older. More specifically, 10 of 11 of predicted clearance values were within 1.5-fold of those observed in children between 1 month and 2 years old. The PopPK approach also predicted 19 of 21 drug clearance within twofold of the observed values in children. In summary, our analysis demonstrated both PBPK and PopPK adult models, after verification with additional adult pharmacokinetic (PK) studies and incorporation of known ontogeny of renal filtration, could be applied for dosing regimen recommendation in children 1 month and older for renally eliminated drugs in a first-in-pediatric study.

Indexed as

Computer SimulationModels, BiologicalAdolescentChildChild, PreschoolClinical Trials as TopicFemaleForecastingHumansInfantInfant, NewbornKidneyMaleMetabolic Clearance RatePharmaceutical PreparationsPharmaceutical Preparations

Identifiers

PMID27566992
PMCPMC5036422
OpenAlexW2509227394

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.