Evidence map›Paper›PMID 29857115›Full record

ArticleRegulatory toxicology and pharmacology : RTP2018

In vitro and in vivo DFO-chelatable labile iron release profiles among commercially available intravenous iron nanoparticle formulations.

Amy Barton Pai, Manjunath P Pai, Dan E Meyer, Brian C Bales, Victoria E Cotero, Nan Zheng, Wenlei Jiang

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Regulatory toxicology and pharmacology : RTP, 2018. 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
0.3field-weighted citation impact, top 39% 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, 8 citations in OpenAlex.

  1. Review
  2. 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

7 authors at 3 institutions in 1 country.

Amy Barton PaiUniversity of Michigan College of Pharmacy, 428 Church Street, Ann Arbor, MI, 48109, USA. Electronic address: amypai@med.umich.edu.
Manjunath P PaiUniversity of Michigan College of Pharmacy, 428 Church Street, Ann Arbor, MI, 48109, USA.
Dan E MeyerGeneral Electric Global Research Center, 1 Research Circle, Niskayuna, NY, 12309, USA.
Brian C BalesGeneral Electric Global Research Center, 1 Research Circle, Niskayuna, NY, 12309, USA.
Victoria E CoteroGeneral Electric Global Research Center, 1 Research Circle, Niskayuna, NY, 12309, USA.
Nan ZhengFood and Drug Administration, Office of Generic Drugs, 10903 New Hampshire Avenue, Silver Spring, MD, 20903, USA.
Wenlei JiangFood and Drug Administration, Office of Generic Drugs, 10903 New Hampshire Avenue, Silver Spring, MD, 20903, USA.
General Electric (United States) · USUnited States Food and Drug Administration · USUniversity of Michigan · US

Funding

XenograftP30CA046592 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Alexey I Nesvizhskii · 1988 to 2026
$178.2M
FDA HHS U01 FD004889NCI NIH HHS P30 CA046592
6 · The paper itself

Abstract

Intravenous (IV) iron formulations are complex colloidal suspensions of iron oxide nanoparticles. Small changes in formulation can allow more labile iron to be released after injection causing toxicity. Thus, bioequivalence (BE) evaluation of generic IV iron formulations remains challenging. We evaluated labile iron release in vitro and in vivo using a high performance liquid chromatography chelatable iron assay to develop a relational model to support BE. In vitro labile iron release and in vivo labile iron pharmacokinetics were evaluated for Venofer

Indexed as

Administration, IntravenousAnimalsChelating AgentsDeferoxamineIron CompoundsKineticsMaleNanoparticlesRatsRats, Sprague-DawleyChelating AgentsDeferoxamineIron CompoundsBioequivalenceIntravenous ironLabile ironPharmacokinetics

Identifiers

PMID29857115
PMCPMC8855972
OpenAlexW2805041650

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.