Influence of Study Design Variables on Clinical Pathology Data.

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."

journal_name

Toxicol Pathol

journal_title

Toxicologic pathology

authors

Aulbach A,Provencher A,Tripathi N

doi

10.1177/0192623316677066

subject

Has Abstract

pub_date

2017-02-01 00:00:00

pages

288-295

issue

2

eissn

0192-6233

issn

1533-1601

journal_volume

45

pub_type

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