Evidence map›Paper›PMID 28762136›Full record

ArticleClinical pharmacokinetics2018

Predicting Cortisol Exposure from Paediatric Hydrocortisone Formulation Using a Semi-Mechanistic Pharmacokinetic Model Established in Healthy Adults.

Johanna Melin, Zinnia P Parra-Guillen, Niklas Hartung, Wilhelm Huisinga, Richard J Ross, Martin J Whitaker, Charlotte Kloft

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Article in Clinical pharmacokinetics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.2field-weighted citation impact, top 19% 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

7 citing papers in PubMed, 17 citations in OpenAlex.

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  7. Chronopharmacology of glucocorticoids.Advanced drug delivery reviews
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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

7 authors at 4 institutions in 2 countries.

Johanna MelinDepartment of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, Kelchstr 31, 12169, Berlin, Germany.
Zinnia P Parra-GuillenDepartment of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, Kelchstr 31, 12169, Berlin, Germany.
Niklas HartungDepartment of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, Kelchstr 31, 12169, Berlin, Germany.
Wilhelm HuisingaInstitute of Mathematics, University of Potsdam, Karl-Liebknecht-Str. 24-25, 14476, Potsdam, Germany.
Richard J RossDepartment of Oncology and Metabolism, University of Sheffield, Medical School, Beech Hill Road, Sheffield, S10 2RX, UK.
Martin J WhitakerDiurnal Limited, Cardiff Medicentre, Heath Park, Cardiff, CF14 4UJ, UK.
Charlotte KloftDepartment of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, Kelchstr 31, 12169, Berlin, Germany. charlotte.kloft@fu-berlin.de.
Freie Universität Berlin · DEUniversity of Potsdam · DEDiurnal (United Kingdom) · GBUniversity of Sheffield · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveOptimisation of hydrocortisone replacement therapy in children is challenging as there is currently no licensed formulation and dose in Europe for children under 6 years of age. In addition, hydrocortisone has non-linear pharmacokinetics caused by saturable plasma protein binding. A paediatric hydrocortisone formulation, Infacort

methodsCortisol and binding protein concentrations were evaluated in the absence and presence of dexamethasone in healthy volunteers (n = 30). Dexamethasone was used to suppress endogenous cortisol concentrations prior to and after single doses of 0.5, 2, 5 and 10 mg of Infacort

resultsBoth specific (non-linear) and non-specific (linear) protein binding were included in the cortisol binding model. A two-compartment disposition model with saturable absorption and constant endogenous cortisol baseline (Baseline

conclusionsOur semi-mechanistic population pharmacokinetic model for hydrocortisone captures the complex pharmacokinetics of hydrocortisone in a simplified but comprehensive framework. The predicted cortisol exposure indicated the importance of defining an accurate hydrocortisone dose to mimic physiological concentrations for neonates and infants weighing <20 kg. EudraCT number: 2013-000260-28, 2013-000259-42.

Indexed as

Models, BiologicalAdministration, IntravenousAdministration, OralAdrenal InsufficiencyAdultAge FactorsChild, PreschoolComputer SimulationDrug CompoundingDrug Dosage CalculationsGlucocorticoidsHormone Replacement TherapyHumansHydrocortisoneInfantInfant, NewbornGlucocorticoidsHydrocortisone

Identifiers

PMID28762136
OpenAlexW2740890599

What OpenQuestion holds

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Registered trials

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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.