Regulatory Toxicology Testing of Pharmaceuticals

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

Toxicologic Pathology ◽

10.1177/0192623320983252 ◽

2021 ◽

pp. 019262332098325

Author(s):

Alys E. Bradley ◽

Maurice G. Cary ◽

Kaori Isobe ◽

Stuart Naylor ◽

Stephen Drew

Keyword(s):

Peer Review ◽

Proof Of Concept ◽

Regulatory Toxicology ◽

Glass Slides ◽

Microscopic Findings ◽

Slight Discrepancy ◽

Whole Slide Images ◽

Diagnostic Discrepancies

This Proof of Concept (POC) study was to assess whether assessment of whole slide images (WSI) of the 2 target tissues for a contemporaneous peer review can elicit concordant results to the findings generated by the Study Pathologist from the glass slides. Well-focused WSI of liver and spleen from 4 groups of mice, that had previously been diagnosed to be the target tissues by an experienced veterinary toxicologic pathologist examining glass slides, were independently reviewed by 3 veterinary pathologists with varying experience in assessment of WSIs. Diagnostic discrepancies were then reviewed by an experienced adjudicating pathologist. Assessment of microscopic findings using WSI showed concordance with the glass slides, with only slight discrepancy in severity grades noted. None of the lesions recorded by the Study pathologist were “missed” and no lesions were added by the pathologists evaluating WSIs, thus demonstrating equivalence of the WSI to glass slides for this study.

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Letter to the Editor in Response to Forristal et al.: Improving the Quality of Risk Assessments in Canada Using a Principle-Based Approach, Regulatory Toxicology and Pharmacology 50 (2008) 336–344

Regulatory Toxicology and Pharmacology ◽

10.1016/j.yrtph.2008.12.001 ◽

2009 ◽

Vol 53 (2) ◽

pp. 156-157

Author(s):

Bette Meek

Keyword(s):

Risk Assessments ◽

Regulatory Toxicology ◽

Letter To The Editor

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Relevance of Animal Studies in Regulatory Toxicology: Current Approaches and Future Opportunities

Alternatives to Laboratory Animals ◽

10.1177/026119299602400208 ◽

1996 ◽

Vol 24 (2) ◽

pp. 173-178

Author(s):

Johannes J.M. van de Sandt ◽

Victor J. Feron

Keyword(s):

Risk Assessment ◽

Risk Evaluation ◽

Animal Studies ◽

Regulatory Toxicology ◽

Animal Test ◽

Toxicity Studies ◽

Increasing Knowledge ◽

Scientific Value

With rapidly increasing knowledge of toxicological processes, the scientific value and relevance of toxicity studies for risk assessment must be re-evaluated. In this paper, it is proposed that the rigid risk evaluation currently required should be replaced by a more flexible, case-by-case approach, in order to increase the relevance of each animal test conducted. The development of new types of toxicity studies and their application in risk evaluation are also described.

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