Evidence map›Paper›PMID 38822557›Full record

ReviewInternational journal of toxicology

Exploring Greater Flexibility for Chronic Toxicity Study Designs to Support Human Safety Assessment While Balancing 3Rs Considerations.

Helen Prior, Paul Baldrick, David O Clarke, Elisa Passini, Fiona Sewell, Peter van Meer

Abstract readReview
In one paragraph

Review 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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. 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

6 authors.

Helen PriorNational Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), London, UK.
Paul BaldrickFortrea, Maidenhead, UK.
David O ClarkeLilly Research Laboratories, Indianapolis, IN, USA.
Elisa PassiniNational Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), London, UK.
Fiona SewellNational Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), London, UK.ORCID 0000-0001-5589-9453
Peter van MeerMedicines Evaluation Board, Utrecht, Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Chronic repeated-dose toxicity studies are required to support long-term dosing in late-stage clinical trials, providing data to adequately characterize adverse effects of potential concern for human safety. Different regulatory guidances for the design and duration of chronic toxicity studies are available, with flexibility in approaches often adopted for specific drug modalities. These guidances may provide opportunities to reduce time, cost, compound requirement and animal use within drug development programs if applied more broadly and considered outside their current scopes of use. This article summarizes presentations from a workshop at the 43

Indexed as

Animal Testing AlternativesToxicity Tests, ChronicAnimalsHumansResearch DesignRisk Assessmentchronic toxicityrecoveryspeciesstudy design

Identifiers

PMID38822557
PMCPMC11408957

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.