Best practices for veterinary toxicologic clinical pathology, with emphasis on the pharmaceutical and biotechnology industries. (25th July 2013)

• Record Type: Journal Article
• Authors: Tomlinson, Lindsay; Boone, Laura I.; Ramaiah, Lila; Penraat, Kelley A.; von Beust, Barbara R.; Ameri, Mehrdad; Poitout‐Belissent, Florence M.; Weingand, Kurt; Workman, Heather C.; Aulbach, Adam D.; Meyer, Dennis J.; Brown, Diane E.; MacNeill, Amy L.; Bolliger, Anne Provencher; Bounous, Denise I.
• Is Part Of: Veterinary clinical pathology. Volume 42:Number 3(2013)
• Page Start: 252
• Page End: 269
• Publication Date: 2013-07-25
• Subjects: Biomarkers -- laboratory standards -- preclinical development -- preclinical safety -- translational medicine; Veterinary pathology -- Periodicals; 636.089607
• DOI: 10.1111/vcp.12059
• Languages: English
• ISSNs: 0275-6382

Abstract

Abstract: The purpose of this paper by the Regulatory Affairs Committee (RAC) of the American Society for Veterinary Clinical Pathology (ASVCP) is to review the current regulatory guidances (eg, guidelines) and published recommendations for best practices in veterinary toxicologic clinical pathology, particularly in the pharmaceutical and biotechnology industries, and to utilize the combined experience of ASVCP RAC to provide updated recommendations. Discussion points include (1) instrumentation, validation, and sample collection, (2) routine laboratory variables, (3) cytologic laboratory variables, (4) data interpretation and reporting (including peer review, reference intervals and statistics), and (5) roles and responsibilities of clinical pathologists and laboratory personnel. Revision and improvement of current practices should be in alignment with evolving regulatory guidance documents, new technology, and expanding understanding and utility of clinical pathology. These recommendations provide a contemporary guide for the refinement of veterinary toxicologic clinical pathology best practices.