Best practices for veterinary toxicologic clinical pathology,with emphasis on the pharmaceutical and biotechnology industries |
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| Authors: | Lindsay Tomlinson Laura I. Boone Lila Ramaiah Kelley A. Penraat Barbara R. von Beust Mehrdad Ameri Florence M. Poitout‐Belissent Kurt Weingand Heather C. Workman Adam D. Aulbach Dennis J. Meyer Diane E. Brown Amy L. MacNeill Anne Provencher Bolliger Denise I. Bounous |
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| Affiliation: | 1. Drug Safety and Research Development, Pfizer, Inc., , Cambridge, MA, USA;2. Covance Laboratories, Inc., , Greenfield, IN, USA;3. Huntingdon Life Sciences, , East Millstone, NJ, USA;4. Alpha‐Omega Veterinary Consultant Services, , Lafayette, NJ, USA;5. Labor am Zugersee, , Hünenberg, Switzerland;6. Department of Pathology, Amgen, Inc., , Thousand Oaks, CA, USA;7. Clinical Pathology, Charles River Laboratories, , Reno, NV, USA;8. Charles River Laboratories, , Montreal, QC, Canada;9. Charles River Laboratories, , Sherbrooke, QC, Canada;10. SciComPro‐LLC, , Phoenix, AZ, USA;11. MPI Research, , Mattawan, MI, USA;12. Department of Pathology, Massachusetts General Hospital, Harvard Medical School, , Boston, MA, USA;13. Department of Pathobiology, University of Illinois, , Urbana, IL, USA;14. Discovery Toxicology, Bristol‐Myers Squibb Company, , Lawrenceville, NJ, USA |
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| 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. |
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| Keywords: | Biomarkers laboratory standards preclinical development preclinical safety translational medicine |
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