Influence of Study Design Variables on Clinical Pathology Data. (February 2017)

• Record Type: Journal Article
• Authors: Aulbach, Adam; Provencher, Anne; Tripathi, Niraj
• Other Names: Aulbach Adam guest-editor.; Jordan Holly guest-editor.; Tarrant Jacqueline guest-editor.
• Is Part Of: Toxicologic pathology. Volume 45:Number 2(2017)
• Page Start: 288
• Page End: 295
• Publication Date: 2017-02
• Subjects: blood sampling -- clinical chemistry -- fasting -- hematology -- housing -- route of administration; Pathology -- Periodicals; Toxicology -- Periodicals; Pathology; Toxicology; 615.9
• DOI: 10.1177/0192623316677066
• Languages: English
• ISSNs: 0192-6233

Abstract

A number of factors related to study design have the potential to impact clinical pathology test results during the conduct of nonclinical safety studies. A thorough understanding of these factors is paramount in drawing accurate conclusions from clinical pathology data generated during such studies, particularly when attempting to make the distinction between test article and nontest article–related effects. Study design and conduct variables with potential to impact clinical pathology data discussed in this overview include those related to species and test system, animal age, animal care and husbandry practices, fasting, acclimatization periods, effects of transportation and stressors, route of administration, effects of in-life and surgical procedures, influence of study length, timing of blood collections, impact of vehicle/formulation composition, and some general concepts related to drug class. The material presented here is a summary based on information presented at the 35th Annual Symposium of the Society of Toxicologic Pathology (June 2016), during Symposium Session 2 titled "Deciphering Sources of Variability in Clinical Pathology—It's Not Just about the Numbers."