Evidence map›Paper›PMID 30676753›Full record

ArticleMolecular pharmaceutics2019

Snapshots of Iron Speciation: Tracking the Fate of Iron Nanoparticle Drugs via a Liquid Chromatography-Inductively Coupled Plasma-Mass Spectrometric Approach.

Heather M Neu, Sergei A Alexishin, Joel E P Brandis, Anne M C Williams, Wenjing Li, Dajun Sun, Nan Zheng, Wenlei Jiang, Ann Zimrin, Jeffrey C Fink and 3 more

Abstract readValidation Study
In one paragraph

Article in Molecular pharmaceutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
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

8 citing papers in PubMed.

  1. Trial
  2. Review
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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

13 authors.

Heather M NeuDepartment of Pharmaceutical Sciences , University of Maryland School of Pharmacy , Baltimore , Maryland 21201 , United States.
Sergei A AlexishinDepartment of Pharmaceutical Sciences , University of Maryland School of Pharmacy , Baltimore , Maryland 21201 , United States.
Joel E P BrandisDepartment of Pharmaceutical Sciences , University of Maryland School of Pharmacy , Baltimore , Maryland 21201 , United States.
Anne M C WilliamsDepartment of Pharmaceutical Sciences , University of Maryland School of Pharmacy , Baltimore , Maryland 21201 , United States.
Wenjing LiDepartment of Pharmaceutical Sciences , University of Maryland School of Pharmacy , Baltimore , Maryland 21201 , United States.
Dajun SunOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research , U.S. Food and Drug Administration , Silver Spring , Maryland 20993 , United States.
Nan ZhengOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research , U.S. Food and Drug Administration , Silver Spring , Maryland 20993 , United States.
Wenlei JiangOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research , U.S. Food and Drug Administration , Silver Spring , Maryland 20993 , United States.
Ann ZimrinOncology Program , University of Maryland School of Medicine , Baltimore , Maryland 21201 , United States.
Jeffrey C FinkDepartment of Medicine , University of Maryland School of Medicine , Baltimore , Maryland 21201 , United States.
James E PolliDepartment of Pharmaceutical Sciences , University of Maryland School of Pharmacy , Baltimore , Maryland 21201 , United States.ORCID 0000-0002-5274-4314
Maureen A KaneDepartment of Pharmaceutical Sciences , University of Maryland School of Pharmacy , Baltimore , Maryland 21201 , United States.
Sarah L J MichelDepartment of Pharmaceutical Sciences , University of Maryland School of Pharmacy , Baltimore , Maryland 21201 , United States.ORCID 0000-0002-6366-2453

Funding

University of Maryland Center of Excellence in Regulatory Science and InnovationU01FD005946 · FDA · UNIV OF MARYLAND, COLLEGE PARK · PI BENTLEY, WILLIAM E., POLLI, JAMES E · 2016 to 2025
$21.5M
Graduate Training at The Chemistry Biology InterfaceT32GM066706 · NIGMS · UNIVERSITY OF MARYLAND BALTIMORE COUNTY · PI SELEY-RADTKE, KATHERINE L, SMITH, AARON T · 2004 to 2023
$3.3M
Evaluation of Iron Species in Healthy Subjects Treated with Generic and Reference Sodium Ferric GluconateU01FD005266 · FDA · UNIVERSITY OF MARYLAND BALTIMORE · PI KANE, MAUREEN A, MICHEL, SARAH L · 2014 to 2018
$2.0M
FDA HHS U01 FD005266FDA HHS U01 FD005946NIGMS NIH HHS T32 GM066706
6 · The paper itself

Abstract

Nanomedicines are nanoparticle-based therapeutic or diagnostic agents designed for targeted delivery or enhanced stability. Nanotechnology has been successfully employed to develop various drug formulations with improved pharmacokinetic characteristics, and current research efforts are focused on the development of new innovator and generic nanomedicines. Nanomedicines, which are often denoted as complex or nonbiological complex drugs, have inherently different physicochemical and pharmacokinetic properties than conventional small molecule drugs. The tools necessary to fully evaluate nanomedicines in clinical settings are limited, which can hamper their development. One of the most successful families of nanomedicines are iron-carbohydrate nanoparticles, which are administered intravenously (IV) to treat iron-deficiency anemia. In the U.S., the FDA has approved six distinct iron-carbohydrate nanoparticles but only one generic version (sodium ferric gluconate for Ferrlecit). There is significant interest in approving additional generic iron-carbohydrate drugs; however, the lack of a direct method to monitor the fate of the iron nanoparticles in clinical samples has impeded this approval. Herein we report a novel liquid chromatography-inductively coupled plasma-mass spectrometry (LC-ICP-MS) method that allows for the direct quantification of the iron-carbohydrate drugs in clinical samples, while simultaneously measuring the speciation of the iron released from the nanoparticles in biological samples. To our knowledge, this is the first time that iron nanoparticles have been observed in clinical samples, opening the door for direct pharmacokinetic studies of this family of drugs. This method has potential applications not only for iron-nanoparticle drugs but also for any nanomedicine with an inorganic component.

Indexed as

Administration, IntravenousChromatography, LiquidData AccuracyDrug CompoundingDrugs, GenericFerric CompoundsHealthy VolunteersHumansIronMass SpectrometryNanomedicineNanoparticlesNanotechnologySensitivity and SpecificityDrugs, GenericFerric Compoundsferric gluconateIroncomplex nonbiological drugdrug-bound ironlabile ironliquid chromatography−inductively coupled plasma−mass spectrometrymetal speciationnanomedicinenontransferrin-bound ironprotein bound ironsodium ferric gluconate

Identifiers

PMID30676753
PMCPMC6900873

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.