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Toxicol Pathol. 2017 Jan;45(1):223-237. doi: 10.1177/0192623316677068. Epub 2016 Nov 14.

Interpreting and Integrating Clinical and Anatomic Pathology Results.

Author information

1
1 Envigo, East Millstone, New Jersey, USA.
2
2 Bristol-Myers Squibb, New Brunswick, New Jersey, USA.
3
3 MedImmune LLC, Gaithersburg, Maryland, USA.
4
4 Novartis Institutes for BioMedical Research, East Hanover, New Jersey, USA.
5
5 GlaxoSmithKline, King of Prussia, Pennsylvania, USA.

Abstract

The continuing education course on integrating clinical and anatomical pathology data was designed to communicate the importance of using a weight of evidence approach to interpret safety findings in toxicology studies. This approach is necessary, as neither clinical nor anatomic pathology data can be relied upon in isolation to fully understand the relationship between study findings and the test article. Basic principles for correlating anatomic pathology and clinical pathology findings and for integrating these with other study end points were reviewed. To highlight these relationships, a series of case examples, presented jointly by a clinical pathologist and an anatomic pathologist, were used to illustrate the collaborative effort required between clinical and anatomical pathologists. In addition, the diagnostic utility of traditional liver biomarkers was discussed using results from a meta-analysis of rat hepatobiliary marker and histopathology data. This discussion also included examples of traditional and novel liver and renal biomarker data implementation in nonclinical toxicology studies to illustrate the relationship between discrete changes in biochemistry and tissue morphology.

KEYWORDS:

biomarkers; clinical chemistry; clinical pathology; correlating; hematology; histopathology; liver toxicology

PMID:
27879439
DOI:
10.1177/0192623316677068
[Indexed for MEDLINE]

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