Evidence map›Paper›PMID 40459370›Full record

ReviewToxicologic pathology2025

Digital Pathology and Artificial Intelligence Applied to Nonclinical Toxicology Pathology-The Current State, Challenges, and Future Directions.

Gabriele Pohlmeyer-Esch, Charles Halsey, Julie Boisclair, Sripad Ram, Sarah Kirschner-Kitz, Brian Knight, Pierre Moulin, Anna-Lena Frisk

Abstract readReview
In one paragraph

Review in Toxicologic pathology, 2025. 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
–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

2 citing papers in PubMed.

  1. Article
  2. Terminally exhausted CD8Frontiers in immunology · 2025
    Review
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

8 authors.

Gabriele Pohlmeyer-EschBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.ORCID 0009-0003-4682-2472
Charles HalseyDrug Safety Research and Development, Pfizer Inc, Groton, Connecticut, USA.ORCID 0009-0004-6976-5578
Julie BoisclairNovartis Pharma AG, Basel, Switzerland.ORCID 0000-0002-3699-5631
Sripad RamDrug Safety Research and Development, Pfizer Inc, Groton, Connecticut, USA.ORCID 0000-0002-9770-106X
Sarah Kirschner-KitzBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.ORCID 0000-0002-9335-9615
Brian KnightBoehringer Ingelheim Inc., Ridgefield, Connecticut, USA.ORCID 0000-0003-2019-3201
Pierre MoulinDeciphex Ltd., Dublin, Ireland.ORCID 0000-0001-5215-8596
Anna-Lena FriskJanssen Pharmaceutica NV, Beerse, Belgium.ORCID 0000-0002-3695-1997

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Advancements in digital pathology and artificial intelligence (AI) have enormous transformative potential for nonclinical toxicologic pathology and are already changing the ways in which pathologists work. However, due to the rapid evolution of digital pathology and AI, the toxicologic pathology community would benefit from an update on these advancements, which can be used to aid drug development. Here we identify key articles published on the use of digital pathology and AI in the field and provide current regulatory statuses and guidelines. For digital pathology, we outline the requirements for equipment, validation processes, workflows, and archiving. Challenges to achieve system interoperability and to establish harmonization through Digital Imaging and Communications in Medicine compatibility are also discussed. For AI, we highlight considerations for model development, including the determination of ground truth, problems that may arise due to bias, and how the accuracy and precision of AI algorithms can be assessed. Finally, we discuss the challenges and potential for AI-assisted toxicologic pathology, picturing a future where technology and scientific expertise work hand-in-hand to improve the quality and efficiency of nonclinical drug safety evaluation. This publication is a deliverable of the European Innovative Medicines Initiative 2 Joint Undertaking, "Bigpicture."

Indexed as

Artificial IntelligenceImage Processing, Computer-AssistedPathologyToxicologyAnimalsHumansartificial intelligencecomputational pathologydigital pathologyGLPregulatory acceptancetoxicologic pathologywhole slide imaging

Identifiers

PMID40459370
PMCPMC12612283

What Socratic 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 Socratic graph.