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Challenges and Opportunities Associated with the Use of Reference Intervals for the Interpretation of Clinical Pathology Data in Target Animal Safety Studies in Veterinary Species (303529)

*Emily R Smith, US Food and Drug Administration 

Keywords: reference intervals, target animal safety, clinical pathology

The interpretation of clinical pathology data in target animal safety studies relies to a large degree on the availability of appropriate reference intervals. This presentation will provide considerations in the selection of appropriate clinical pathology reference intervals for various types of target animal safety studies, a discussion of challenges associated with the development of reference intervals for special target animal safety populations, and examples of how reference intervals are integrated into descriptive statistics and used along with the statistical analysis to draw conclusions from the clinical pathology data and identify potential safety concerns.