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Related Experiment Video

Updated: Jun 4, 2026

High Content Screening Analysis to Evaluate the Toxicological Effects of Harmful and Potentially Harmful Constituents (HPHC)

High Content Screening Analysis to Evaluate the Toxicological Effects of Harmful and Potentially Harmful Constituents (HPHC)

Published on: May 10, 2016

Best practices for clinical pathology testing in carcinogenicity studies.

Jamie K Young¹, Robert L Hall, Peter O'Brien

¹Covance Laboratories, Greenfield, Indiana, USA. jamie.k.young@covance.com

Toxicologic Pathology

|February 8, 2011

Summary

Clinical pathology testing in carcinogenicity studies should be limited, focusing on blood smears for hematopoietic neoplasia diagnosis. This approach ensures efficient use of resources in toxicologic pathology research.

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Last Updated: Jun 4, 2026

High Content Screening Analysis to Evaluate the Toxicological Effects of Harmful and Potentially Harmful Constituents (HPHC)

High Content Screening Analysis to Evaluate the Toxicological Effects of Harmful and Potentially Harmful Constituents (HPHC)

Published on: May 10, 2016

Area of Science:

Veterinary Pathology
Toxicologic Pathology
Carcinogenicity Studies

Background:

The Society of Toxicologic Pathology (STP) and American Society for Veterinary Clinical Pathology (ASCVP) formed a working group to establish best practices.
Existing regulatory guidance and literature were reviewed, alongside a global survey of veterinary pathologists' current practices and recommendations.

Purpose of the Study:

To recommend best practices for incorporating clinical pathology testing into carcinogenicity studies.
To provide guidance on the appropriate use and limitations of clinical pathology in evaluating potential carcinogens.

Main Methods:

Review of regulatory documents and scientific literature.
Survey of veterinary pathologists across North America, Japan, and Europe.
Consensus recommendations developed by a working group.

Main Results:

For two-year rodent carcinogenicity studies, clinical pathology testing should be restricted to blood smears at sacrifice, examined only if hematologic neoplasia is suspected post-histopathology.
Additional clinical pathology is recommended only for specific issues arising from prior toxicity studies or known test article effects.
Insufficient data exist for recommendations on six-month genetically modified mouse carcinogenicity assays, though a similar approach to two-year studies is suggested.

Conclusions:

Limited clinical pathology testing, primarily focused on blood smears for specific diagnostic needs, is recommended for standard carcinogenicity studies.
The value of extensive clinical pathology in these studies is questioned, advocating for targeted application.
Further research is needed to define the role of clinical pathology in alternative carcinogenicity models.