Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2019 Sep;48(3):383-388.
doi: 10.1111/vcp.12773. Epub 2019 Sep 24.

Interpretative considerations for clinical pathology findings in nonclinical toxicology studies

Adam Aulbach  1 , Allison Vitsky  2 , Tara Arndt  3 , Lila Ramaiah  4 , Michael Logan  5 , William Siska  6 , Laura Cregar  1 , Niraj Tripathi  3 , Adeyemi Adedeji  7 , Anne Provencher  8 , Ara Gupta  9 , Holly Jordan  3 , Denise Bounous  10 , Laura Boone  3
Affiliations
Review

Interpretative considerations for clinical pathology findings in nonclinical toxicology studies

Adam Aulbach et al. Vet Clin Pathol. 2019 Sep.

Abstract

The interpretation of clinical pathology results from nonclinical safety studies is a fundamental component in hazard identification of new drug candidates. The ever-increasing complexity of nonclinical safety studies and sophistication of modern analytical methods have made the interpretation of clinical pathology information by a highly trained subject matter expert imperative. Certain interpretive techniques are particularly effective in the identification and characterization of clinical pathology effects. The purpose of this manuscript is to provide an overview of contemporary interpretive practices for clinical pathology results and to provide nonbinding recommendations aimed at improving consistency, quality, and overall value of clinical pathology interpretations generated in support of nonclinical toxicology studies.

Keywords: Clinical pathology; interpretation; nonclinical studies; reporting; toxicology.

PubMed Disclaimer

References

REFERENCES

    1. Ramaiah L, Tomlinson L, Tripathi N, et al. Principles for assessing adversity in toxicological clinical pathology. Toxicol Pathol. 2017;45(2):260-266.
    1. Aulbach A, Vitsky A, Arndyt T, et al. Reporting of clinical pathology interpretations in nonclinical toxicology studies: points to consider I. Vet Clin Pathol (in press).
    1. Kerlin R, Bolon B, Burkhardt J, et al. Scientific and regulatory policy committee: recommended (‘‘best’’) practices for determining, communicating, and using adverse effect data from nonclinical studies. Toxicol Pathol. 2016;44:147-162.
    1. Hall R. Practical considerations in clinical pathology data interpretation and description: the use of statistics, reference intervals, and severity descriptors. Toxicol Pathol. 2017;45(2):362-365.
    1. Hall R. Lies, damn lies, and reference intervals (or hysterical control values for clinical pathology data). Toxicol Pathol. 1997;25(6):647-649; discussion 650-641.

LinkOut - more resources