title: Best practices for veterinary toxicologic clinical pathology, with emphasis on the pharmaceutical and biotechnology industries.
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.
authors.affiliation: Drug Safety and Research Development, Pfizer, Inc., Cambridge, MA, USA.
authors.forename: Lindsay
authors.initials: L
authors.lastname: Tomlinson
authors.forename: Laura I
authors.initials: LI
authors.lastname: Boone
authors.forename: Lila
authors.initials: L
authors.lastname: Ramaiah
authors.forename: Kelley A
authors.initials: KA
authors.lastname: Penraat
authors.forename: Barbara R
authors.initials: BR
authors.lastname: von Beust
authors.forename: Mehrdad
authors.initials: M
authors.lastname: Ameri
authors.forename: Florence M
authors.initials: FM
authors.lastname: Poitout-Belissent
authors.forename: Kurt
authors.initials: K
authors.lastname: Weingand
authors.forename: Heather C
authors.initials: HC
authors.lastname: Workman
authors.forename: Adam D
authors.initials: AD
authors.lastname: Aulbach
authors.forename: Dennis J
authors.initials: DJ
authors.lastname: Meyer
authors.forename: Diane E
authors.initials: DE
authors.lastname: Brown
authors.forename: Amy L
authors.initials: AL
authors.lastname: MacNeill
authors.forename: Anne Provencher
authors.initials: AP
authors.lastname: Bolliger
authors.forename: Denise I
authors.initials: DI
authors.lastname: Bounous
mesh_terms: D000818:Animals; D001709:Biotechnology / Q000592:standards*; D004345:Drug Industry / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000662:veterinary; D007753:Laboratories / Q000592:standards*; D017056:Medical Laboratory Personnel / Q000592:standards*; D010338:Pathology, Clinical / Q000592:standards*; D010341:Pathology, Veterinary / Q000592:standards*; D017410:Practice Guidelines as Topic; D011786:Quality Control; D012958:Societies, Scientific; D014116:Toxicology; D014481:United States
keywords: Biomarkers; laboratory standards; preclinical development; preclinical safety; translational medicine