Evidence map›Paper›PMID 24854092›Full record

ArticleBiomaterials2014

Dose ranging, expanded acute toxicity and safety pharmacology studies for intravenously administered functionalized graphene nanoparticle formulations.

Shruti Kanakia, Jimmy D Toussaint, Sayan Mullick Chowdhury, Tanuf Tembulkar, Stephen Lee, Ya-Ping Jiang, Richard Z Lin, Kenneth R Shroyer, William Moore, Balaji Sitharaman

Open access · greenAbstract read
In one paragraph

Article in Biomaterials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 51 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 1 pooled it
9.6field-weighted citation impact, top 1% 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

51 citing papers in PubMed, 1 synthesis or guideline pooled it, 135 citations in OpenAlex.

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  13. Nanoparticle-based Gene Therapy for Neurodegenerative Disorders.Mini reviews in medicinal chemistry · 2024
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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

10 authors at 1 institution in 1 country.

Shruti KanakiaDepartment of Biomedical Engineering, Stony Brook University, Stony Brook, NY, USA.
Jimmy D ToussaintDepartment of Biomedical Engineering, Stony Brook University, Stony Brook, NY, USA.
Sayan Mullick ChowdhuryDepartment of Biomedical Engineering, Stony Brook University, Stony Brook, NY, USA.
Tanuf TembulkarDepartment of Biomedical Engineering, Stony Brook University, Stony Brook, NY, USA.
Stephen LeeDepartment of Biomedical Engineering, Stony Brook University, Stony Brook, NY, USA.
Ya-Ping JiangDepartment of Physiology and Biophysics, Stony Brook University, Stony Brook, NY, USA.
Richard Z LinDepartment of Physiology and Biophysics, Stony Brook University, Stony Brook, NY, USA.
Kenneth R ShroyerDepartment of Pathology, Stony Brook University, Stony Brook, NY, USA.
William MooreDepartment of Radiology, Stony Brook University, Stony Brook, NY, USA.
Balaji SitharamanDepartment of Biomedical Engineering, Stony Brook University, Stony Brook, NY, USA. Electronic address: balaji.sitharaman@stonybrook.edu.
Stony Brook University · US

Funding

Gq-Coupled Receptors Inhibit PI 3-Kinase/Akt Signaling PathwayR01DK062722 · NIDDK · STATE UNIVERSITY NEW YORK STONY BROOK · PI LIN, RICHARD Z · 2002 to 2012
$3.1M
Preclinical Efficacy And Safety Evaluation Of Graphene Nanoparticle-based Magnetic Resonance Imaging Contrast Agent For Diagnosis of Renal FailureR44DK100205 · NIDDK · THERAGNOSTIC TECHNOLOGIES, INC. · PI SITHARAMAN, BALAJI, TOUSSAINT, JIMMY DEON · 2015 to 2016
$1.5M
Preclinical Efficacy And Safety Evaluation Of Graphene Nanoparticle-based MagnetiR41DK100205 · NIDDK · THERAGNOSTIC TECHNOLOGIES, INC. · PI SITHARAMAN, BALAJI · 2013 to 2013
$160k
NIDDK NIH HHS 1R41DK100205-01A1NIDDK NIH HHS DK62722NIDDK NIH HHS R01 DK062722NIDDK NIH HHS R41 DK100205NIDDK NIH HHS R44 DK100205
6 · The paper itself

Abstract

Graphene nanoparticle dispersions show immense potential as multifunctional agents for in vivo biomedical applications. Herein, we follow regulatory guidelines for pharmaceuticals that recommend safety pharmacology assessment at least 10-100 times higher than the projected therapeutic dose, and present comprehensive single dose response, expanded acute toxicology, toxicokinetics, and respiratory/cardiovascular safety pharmacology results for intravenously administered dextran-coated graphene oxide nanoplatelet (GNP-Dex) formulations to rats at doses between 1 and 500 mg/kg. Our results indicate that the maximum tolerable dose (MTD) of GNP-Dex is between 50 mg/kg ≤ MTD < 125 mg/kg, blood half-life < 30 min, and majority of nanoparticles excreted within 24 h through feces. Histopathology changes were noted at ≥250 mg/kg in the heart, liver, lung, spleen, and kidney; we found no changes in the brain and no GNP-Dex related effects in the cardiovascular parameters or hematological factors (blood, lipid, and metabolic panels) at doses < 125 mg/kg. The results open avenues for pivotal preclinical single and repeat dose safety studies following good laboratory practices (GLP) as required by regulatory agencies for investigational new drug (IND) application.

Indexed as

Administration, IntravenousAnimalsCoated Materials, BiocompatibleDextransDose-Response Relationship, DrugDrug Evaluation, PreclinicalGraphiteHalf-LifeKidneyLiverLungMaleMaximum Tolerated DoseNanoparticlesRatsRats, WistarCoated Materials, BiocompatibleDextransGraphiteBiodistributionDextranDose rangeGraphene nanoplateletsMaximum tolerated doseToxicity

Identifiers

PMID24854092
PMCPMC4104699
OpenAlexW2019903255

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.