Evidence map›Paper›PMID 31957010›Full record

ArticleClinical pharmacology and therapeutics2020

Mechanistic Population Pharmacokinetic Model of Oseltamivir and Oseltamivir Carboxylate Accounting for Physiological Changes to Predict Exposures in Neonates and Infants.

Leonid Gibiansky, Patanjali Ravva, Neil J Parrott, Rajinder Bhardwaj, Elke Zwanziger, Paul Grimsey, Barry Clinch, Stefan Sturm

Open access · hybridAbstract read
In one paragraph

Article in Clinical pharmacology and therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 32% 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

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. 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

8 authors at 4 institutions in 3 countries.

Leonid GibianskyQuantPharm LLC, North Potomac, Maryland, USA.
Patanjali RavvaRoche Innovation Center New York, Roche Pharmaceutical Research and Early Development, New York, New York, USA.
Neil J ParrottRoche Innovation Center Basel, Roche Pharmaceutical Research and Early Development, Basel, Switzerland.
Rajinder BhardwajIntegrated Drug Development, Certara Strategic Consulting, Parsippany, New Jersey, USA.
Elke ZwanzigerRoche Innovation Center Basel, Roche Pharmaceutical Research and Early Development, Basel, Switzerland.
Paul GrimseyRoche Innovation Center Welwyn, Roche Pharmaceutical Research and Early Development, Welwyn Garden City, UK.
Barry ClinchRoche Products Limited, Product Development, Welwyn Garden City, UK.
Stefan SturmRoche Innovation Center Basel, Roche Pharmaceutical Research and Early Development, Basel, Switzerland.
Roche (Switzerland) · CHRoche (United Kingdom) · GBCertara (United States) · USLa Roche College · US

Funding

CLINICAL TRIALS FOR ANTIVIRAL THERAPIES-266030025-266030025N01AI030025 · NIAID · UNIVERSITY OF ALABAMA BIRMINGH · PI WHITLEY, RICHARD R · 2003 to 2006
–
NIAID NIH HHS N01 AI030025
6 · The paper itself

Abstract

A mechanistic population-pharmacokinetic model was developed to predict oseltamivir exposures in neonates and infants accounting for physiological changes during the first 2 years of life. The model included data from 13 studies, comprising 436 subjects with normal renal function (317 pediatric subjects (≥ 38 weeks postmenstrual age (PMA), ≥ 13 days old) and 119 adult subjects < 40 years). Concentration-time profiles of oseltamivir and its active metabolite, oseltamivir carboxylate (OC), were characterized by a four-compartment model, with absorption described by three additional compartments. Renal maturational changes were implemented by description of OC clearance with allometric function of weight and Hill function of PMA. Clearance of OC increased with weight up to 43 kg (allometric coefficient 0.75). Half the adult OC clearance was reached at a PMA of 45.6 weeks (95% confidence interval (CI) 41.6-49.6) with a Hill coefficient of 2.35 (95% CI 1.67-3.04). The model supports the European Union/United States-approved 3 mg/kg twice-daily oseltamivir dose for infants < 1 year (PMA ≥ 38 weeks) and allows prediction of exposures in preterm neonates.

Indexed as

Models, BiologicalAdultAge FactorsAntiviral AgentsBody WeightDose-Response Relationship, DrugFemaleHumansInfantInfant, NewbornKidneyMaleOseltamivirAntiviral AgentsOseltamiviroseltamivir carboxylate

Identifiers

PMID31957010
PMCPMC7325316
OpenAlexW2999328276

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.