Evidence map›Paper›PMID 24561264›Full record

ArticleClinica chimica acta; international journal of clinical chemistry2014

Development and bioanalytical validation of a liquid chromatographic-tandem mass spectrometric (LC-MS/MS) method for the quantification of the CCR5 antagonist maraviroc in human plasma.

Joshua F Emory, Lauren A Seserko, Mark A Marzinke

Abstract readValidation Study
In one paragraph

Article in Clinica chimica acta; international journal of clinical chemistry, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.5field-weighted citation impact, top 18% 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

13 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
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  7. Review
  8. Article
  9. Review
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  11. Maraviroc: a review of its use in HIV infection and beyond.Drug design, development and therapy · 2015
    Review
  12. CYP3A5 genotype impacts maraviroc concentrations in healthy volunteers.Drug metabolism and disposition: the biological fate of chemicals · 2014
    Article
  13. 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

3 authors at 1 institution in 1 country.

Joshua F EmoryDepartment of Medicine, Johns Hopkins University, 600N. Wolfe St., Osler 500, Baltimore, MD 21287, United States.
Lauren A SeserkoDepartment of Medicine, Johns Hopkins University, 600N. Wolfe St., Osler 500, Baltimore, MD 21287, United States.
Mark A MarzinkeDepartment of Medicine, Johns Hopkins University, 600N. Wolfe St., Osler 500, Baltimore, MD 21287, United States; Department of Pathology, Johns Hopkins University, 600N. Wolfe St., Osler 500, Baltimore, MD 21287, United States. Electronic address: mmarzin1@jhmi.edu.
Johns Hopkins University · US

Funding

Microbicide Trials NetworkUM1AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2011 to 2021
$175.0M
LC: HIV Prevention Trials Network - Laboratory Support for the SARS-CoV-2 Seroprevalence Study (CoVPN 5002)UM1AI068613 · NIAID · JOHNS HOPKINS UNIVERSITY · PI SUSAN H ESHLEMAN, Mark A Marzinke · 2011 to 2026
$100.2M
NIAID NIH HHS UM1 AI068613NIAID NIH HHS UM1-AI068613NIAID NIH HHS UM1 AI068633
6 · The paper itself

Abstract

backgroundMaraviroc is a CCR5 antagonist that has been utilized as a viral entry inhibitor in the management of HIV-1. Current clinical trials are pursuing maraviroc drug efficacy in both oral and topical formulations. Therefore, in order to fully understand drug pharmacokinetics, a sensitive method is required to quantify plasma drug concentrations.

methodsMaraviroc-spiked plasma was combined with acetonitrile containing an isotopically-labeled internal standard, and following protein precipitation, samples were evaporated to dryness and reconstituted for liquid chromatographic-tandem mass spectrometric (LC-MS/MS) analysis. Chromatographic separation was achieved on a Waters BEH C8, 50×2.1 mm UPLC column, with a 1.7 μm particle size and the eluent was analyzed using an API 4000 mass analyzer in selected reaction monitoring mode. The method was validated as per FDA Bioanalytical Method Validation guidelines.

resultsThe analytical measuring range of the LC-MS/MS method is 0.5-1000 ng/ml. Calibration curves were generated using weighted 1/x(2) quadratic regression. Inter-and intra-assay precision was ≤5.38% and ≤5.98%, respectively; inter-and intra-assay accuracy (%DEV) was ≤10.2% and ≤8.44%, respectively. Additional studies illustrated similar matrix effects between maraviroc and its internal standard, and that maraviroc is stable under a variety of conditions. Method comparison studies with a reference LC-MS/MS method show a slope of 0.948 with a Spearman coefficient of 0.98.

conclusionsBased on the validation metrics, we have generated a sensitive and automated LC-MS/MS method for maraviroc quantification in human plasma.

Indexed as

Chromatography, High Pressure LiquidTandem Mass SpectrometryCalibrationCCR5 Receptor AntagonistsCyclohexanesHIV Fusion InhibitorsHumansMaravirocReference StandardsReproducibility of ResultsTriazolesCCR5 Receptor AntagonistsCyclohexanesHIV Fusion InhibitorsMaravirocTriazolesAssay validationCCR5 antagonistHIVLC-MS/MSMaraviroc

Identifiers

PMID24561264
PMCPMC4029414
OpenAlexW2028562327

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.