Evidence map›Paper›PMID 38665214›Full record

ArticleFrontiers in toxicology2024

ICH S1 prospective evaluation study: weight of evidence approach to predict outcome and value of 2-year rat carcinogenicity studies. A report from the regulatory authorities subgroup.

Todd Bourcier, Timothy McGovern, Tania Cavaliero, Geoffrey Ebere, Akiyoshi Nishikawa, Jihei Nishimura, Kumiko Ogawa, Markku Pasanen, Alisa Vespa, Jan Willem Van der Laan

Abstract read
In one paragraph

Article in Frontiers in toxicology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

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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.

Todd BourcierFood and Drug Administration, Silver Spring, MD, United States.
Timothy McGovernFood and Drug Administration, Silver Spring, MD, United States.
Tania CavalieroSwissmedic, Swiss Agency for Therapeutic Products, Bern, Switzerland.
Geoffrey EbereHealth Canada, Pharmaceutical Drugs Directorate, Ottawa, ON, Canada.
Akiyoshi NishikawaNational Institute of Health Sciences, Kanagawa, Japan.
Jihei NishimuraPharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Kumiko OgawaNational Institute of Health Sciences, Kanagawa, Japan.
Markku PasanenFaculty of Health Sciences, School of Pharmacy, University of Eastern Finland, Kuopio, Finland.
Alisa VespaHealth Canada, Pharmaceutical Drugs Directorate, Ottawa, ON, Canada.
Jan Willem Van der LaanMedicines Evaluation Board, Utrecht, Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

PubMed holds no abstract for this paper.

Indexed as

3R principlesbioassaycarcinogenicityICH S1B(R1)pharmaceuticalsrisk assessmentweight of evidence

Identifiers

PMID38665214
PMCPMC11043531

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.