Scientific and Regulatory Policy Committee Brief Communication: 2019 Survey on Use of Digital Histopathology Systems in Nonclinical Toxicology Studies

Article Pathology

The Application, Challenges, and Advancement Toward Regulatory Acceptance of Digital Toxicologic Pathology: Results of the 7th ESTP International Expert Workshop (September 20-21, 2019)

Vanessa L. Schumacher et al.

Summary: Advancements in digital pathology have led to increased adoption in human medical pathology, but challenges remain in toxicologic pathology, particularly in regulatory studies. International workshops are being held to assess current applications, challenges, and outline minimal requirements for gaining regulatory acceptance in toxicologic pathology workflows.

TOXICOLOGIC PATHOLOGY (2021)

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Article Pathology

Proof of Concept: The Use of Whole-Slide Images (WSI) for Peer Review of Tissues on Routine Regulatory Toxicology Studies

Alys E. Bradley et al.

Summary: This study demonstrated that assessment of whole slide images (WSI) can elicit concordant results to the findings generated from glass slides, showing equivalence between WSI and glass slides for the study.

TOXICOLOGIC PATHOLOGY (2021)

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Article Pathology

Utilizing Whole Slide Images for the Primary Evaluation and Peer Review of a GLP-Compliant Rodent Toxicology Study

Matt Jacobsen et al.

Summary: The study describes the approach taken to validate GLP compliance for digital primary evaluation and peer review in a rodent inhalation toxicity study. Validation was carried out for the slide scanner, software, and database software, establishing a GLP validated environment for primary histopathologic evaluation using WSIs. The use of a cloud-based digital pathology platform allowed for flexibility in global working and potential future reuse of digitized data for advanced image analysis technologies.

TOXICOLOGIC PATHOLOGY (2021)

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Article Pathology