Evidence map›Paper›PMID 25274608›Full record

ArticleThe AAPS journal2014

Prediction of drug clearance in children: an evaluation of the predictive performance of several models.

Iftekhar Mahmood, Carl-Michael Staschen, Kosalaram Goteti

Open access · bronzeAbstract read
In one paragraph

Article in The AAPS journal, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
7.1field-weighted citation impact, top 4% 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

16 citing papers in PubMed, 50 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

3 authors at 2 institutions in 2 countries.

Iftekhar MahmoodDivision of Hematology, Office of Blood Review & Research (OBRR), Center for Biologic Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993-0002, USA, iftekhar.mahmood@fda.hhs.gov.
Carl-Michael Staschen
Kosalaram Goteti
Food and Drug Administration · THPfizer (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The objective of this study is to evaluate the predictive performance of several models to predict drug clearance in children ≤5 years of age. Six models (allometric model (data-dependent exponent), fixed exponent of 0.75 model, maturation model, body weight-dependent model, segmented allometric model, and age-dependent exponent model) were evaluated in this study. From the literature, the clearance values for six drugs from neonates to adults were obtained. External data were used to evaluate the predictive performance of these models in children ≤5 years of age. With the exception of a fixed exponent of 0.75, the mean predicted clearance in most of the age groups was within ≤50% prediction error. Individual clearance prediction was erratic by all models and cannot be used reliably to predict individual clearance. Maturation, body weight-dependent, and segmented allometric models to predict clearances of drugs in children ≤5 years of age are of limited practical value during drug development due to the lack of availability of data. Age-dependent exponent model can be used for the selection of first-in-children dose during drug development.

Indexed as

Models, BiologicalAge FactorsAgingBody WeightChildChild, PreschoolData Interpretation, StatisticalHumansInfantInfant, NewbornInfant, PrematureMetabolic Clearance RatePharmaceutical PreparationsPharmaceutical Preparations

Identifiers

PMID25274608
PMCPMC4389735
OpenAlexW2055498861

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.