Best practices for veterinary toxicologic clinical pathology, with emphasis on the pharmaceutical and biotechnology industries

Authors


  • Position Statements and Special Reports developed by the American Society for Veterinary Clinical Pathology (ASVCP) provide current information on topics in veterinary clinical pathology that are important to the veterinary community. The procedure for submitting statements is detailed at www.asvcp.org/membersonly/positionpapers.cfm. The ASVCP Executive Board is responsible for the review and approval of all statements, often following a period of input from the ASVCP membership and experts in the field. The final draft is then submitted to Veterinary Clinical Pathology and is edited prior to publication. The recommendations contained in this manuscript have also been endorsed by the Society of Toxicologic Pathologists (STP).

Correspondence

Lindsay Tomlinson, Drug Safety and Research Development, Pfizer, Inc., Cambridge, MA, USA

E-mail: lindsay.tomlinson@pfizer.com

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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