In:
International Journal of Toxicology, SAGE Publications, Vol. 36, No. 4 ( 2017-07), p. 293-302
Abstract:
Clinical pathology testing is routinely performed in target animal safety studies in order to identify potential toxicity associated with administration of an investigational veterinary pharmaceutical product. Regulatory and other testing guidelines that address such studies provide recommendations for clinical pathology testing but occasionally contain outdated analytes and do not take into account interspecies physiologic differences that affect the practical selection of appropriate clinical pathology tests. Additionally, strong emphasis is often placed on statistical analysis and use of reference intervals for interpretation of test article–related clinical pathology changes, with limited attention given to the critical scientific review of clinically, toxicologically, or biologically relevant changes. The purpose of this communication from the Regulatory Affairs Committee of the American Society for Veterinary Clinical Pathology is to provide current recommendations for clinical pathology testing and data interpretation in target animal safety studies and thereby enhance the value of clinical pathology testing in these studies.
Type of Medium:
Online Resource
ISSN:
1091-5818
,
1092-874X
DOI:
10.1177/1091581817711876
Language:
English
Publisher:
SAGE Publications
Publication Date:
2017
detail.hit.zdb_id:
1500682-7
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