Evidence map›Paper›PMID 32056156›Full record

ArticleDrugs in R&D2020

Prediction of Clearance in Children from Adults Following Drug-Drug Interaction Studies: Application of Age-Dependent Exponent Model.

Iftekhar Mahmood

Open access · goldAbstract read
In one paragraph

Article in Drugs in R&D, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
2.3field-weighted citation impact, top 13% 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

2 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. A comparison of different methods for the first-in-pediatric dose selection.Journal of clinical and translational research · 2022
    Article
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

1 author at 1 institution in 2 countries.

Iftekhar MahmoodOffice of Tissue and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993-0002, USA. Iftekharmahmood@aol.com.ORCID http://orcid.org/0000-0003-1311-4237
Center for Biologics Evaluation and Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivePharmacokinetic drug-drug interaction (DDI) studies are conducted in adult subjects during drug development but there are limited studies that have characterized pharmacokinetic DDI studies in children. The objective of this study was to evaluate if the DDI clearance values from adults can be allometrically extrapolated from adults to children.

methodsFifteen drugs were included in this study and the age of the children ranged from premature neonates to adolescents (30 observations across the age groups). The age-dependent exponent (ADE) model was used to predict the clearance of drugs in children from adults following DDI studies.

resultsThe prediction error of drug clearances following DDIs in children ranged from 4 to 67%. Of 30 observations, 17 (57%) and 27 (90%) observations had a prediction error ≤ 30% and ≤ 50%, respectively.

conclusionThis study indicates that it is possible to predict the clearance of drugs with reasonable accuracy in children from adults following DDI studies using an ADE model. The method is simple, robust, and reliable and can replace other complex empirical models.

Indexed as

Metabolic Clearance RateModels, BiologicalAdolescentAdultChildChild, PreschoolDrug InteractionsHumansInfantInfant, NewbornPharmaceutical PreparationsPharmaceutical Preparations

Identifiers

PMID32056156
PMCPMC7067713
OpenAlexW3005594245

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.