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Review
. 2019 Sep;48(3):389-399.
doi: 10.1111/vcp.12772.

Overview and considerations for the reporting of clinical pathology interpretations 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

Overview and considerations for the reporting of clinical pathology interpretations in nonclinical toxicology studies

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

Abstract

Clinical pathology reporting practices are diverse among individuals and organizations involved in nonclinical toxicology studies. Clear, informative, and consistent reporting of clinical pathology results increases their value and avoids misinterpretation, resulting in decreased drug development costs. In recent years, certain common practices in clinical pathology reporting have been embraced by industry leaders and more consistently utilized across the pharmaceutical industry. The purpose of this manuscript is to review current clinical pathology reporting practices and to provide nonbinding suggestions to improve consistency, quality, and value of clinical pathology reports generated in support of nonclinical toxicology studies.

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

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References

REFERENCES

    1. Morton D, Kemp RK, Francke-Carroll S, et al. Best practices for reporting pathology interpretations within GLP toxicology studies. Toxicol Pathol. 2006;34(6):806-809.
    1. Hall RL.Principles of clinical pathology. In: Sahota PS, Popp JA, Hardisty JF, Gopinath C, eds. Toxicologic Pathology: Nonclinical Safety Assessment. London: CRC Press; 2013:133-173.
    1. Hall RL, Everds NE.Principles of clinical pathology for toxicology studies. In: Hayes AW, Kruger CL, eds. Hayes' Principles and Methods of Toxicology. London: CRC Press; 2014:1305-1344.
    1. Sahota PS, Popp JA, Hardisty JF, et al. Toxicologic Pathology: Nonclinical Safety Assessment. London: CRC Press; 2013:133-173.
    1. Everds NE. Deciphering sources of variability in clinical pathology-It's not just about the numbers: preanalytical considerations. Toxicol Pathol. 2017;45(2):275-280.

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