Evidence map›Paper›PMID 38501993›Full record

ArticleInternational journal of toxicology

Hepatitis A Virus Infection in Cynomolgus Monkeys Confounds the Safety Evaluation of a Drug Candidate.

Chris J Powell, John C Kapeghian, John C Bernal, John R Foster

Open access · hybridAbstract read
In one paragraph

Article in International journal of toxicology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.9field-weighted citation impact, top 28% 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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. 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

4 authors at 4 institutions in 3 countries.

Chris J PowellMRC Toxicology Unit, University of Cambridge, Cambridge, UK.ORCID 0000-0002-3591-3593
John C KapeghianPreclinical Safety Associates, LLC, The Woodlands, TX, USA.
John C BernalCORES Veterinary Consulting, Walnut Grove, TX, USA.
John R FosterToxPath Sciences Ltd, Congleton, UK.
Eugene O'Neill Theater Center · USMurphy Oil Corporation (United States) · USRetriev Technologies (United States) · USUniversity of Cambridge · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In a 3-month toxicity study in cynomolgus monkeys at a European contract laboratory, animals were infected with HAV, initially resulting in hepatic injury being incorrectly attributed to the test compound. Elevated serum ALT/AST/GLDH (5- to 10-fold) were noted in individual animals from all groups including controls, with no apparent dose, exposure, or time-related relationship. Liver histopathology revealed minimal to slight inflammatory cell accumulation in periportal zones of most animals, and minimal to slight hepatocyte degeneration/necrosis in 10/42 animals from all groups. As these findings were more pronounced in 6 drug-treated animals, including 2/6 in the low dose group, the draft report concluded: "

Indexed as

Hepatitis ALiverMacaca fascicularisAlanine TransaminaseAnimalsChemical and Drug Induced Liver InjuryFemaleHepatitis A virusMaleToxicity TestsAlanine Transaminasecynomolgus monkeydrug developmenthepatic pathologyhepatitis A virushepatotoxicitynon-human primatesafety evaluationtoxicology

Identifiers

PMID38501993
PMCPMC11155213
OpenAlexW4392951760

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.