Interpretative considerations for clinical pathology findings in nonclinical toxicology studies. (24th September 2019)

• Record Type: Journal Article
• Authors: Aulbach, Adam; Vitsky, Allison; Arndt, Tara; Ramaiah, Lila; Logan, Michael; Siska, William; Cregar, Laura; Tripathi, Niraj; Adedeji, Adeyemi; Provencher, Anne; Gupta, Ara; Jordan, Holly; Bounous, Denise; Boone, Laura
• Is Part Of: Veterinary clinical pathology. Volume 48:Number 3(2019)
• Page Start: 383
• Page End: 388
• Publication Date: 2019-09-24
• Subjects: Clinical pathology -- interpretation -- nonclinical studies -- reporting -- toxicology; Veterinary pathology -- Periodicals; 636.089607
• DOI: 10.1111/vcp.12773
• Languages: English
• ISSNs: 0275-6382

Abstract

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.