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Deciphering Sources of Variability in Clinical Pathology
Niraj K Tripathi1, Nancy E Everds2, A Eric Schultze3
11 Covance, Madison, Wisconsin, USA.
Toxicologic Pathology
|November 3, 2016
Summary
Variability in clinical pathology data from toxicity studies can obscure test article effects. Understanding preanalytical, analytical, and study design factors is crucial for accurate data interpretation.
Area of Science:
- Toxicologic Pathology
- Clinical Pathology
- Preclinical Research
Background:
- Clinical pathology data in toxicity testing is subject to significant variability.
- This variability can complicate the differentiation between test article-induced effects and experimental procedure artifacts.
Purpose of the Study:
- To explore sources of variability in clinical pathology data within toxicity studies.
- To highlight challenges in data interpretation arising from preanalytical, analytical, and study design factors.
Main Methods:
- Synopsis of presentations from the 35th Annual Symposium of the Society of Toxicologic Pathology.
- Focus on preanalytical and analytical variables, study design, and procedural influences on data.
Main Results:
- Variability stems from animal physiology, sample collection, specimen handling, and analysis.
- Study design and statistical analysis, including reference intervals, significantly impact data interpretation.
Conclusions:
- Managing variables in sample collection, handling, and analysis is essential.
- Accurate interpretation of clinical pathology data in toxicity studies requires careful consideration of all influencing factors.
Keywords:
analytical variablesclinical pathologydata interpretationpreanalytical variablesquality controlstudy designunexpected data variationMore Related Videos
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