title: Background Pathological Changes in Minipigs: A Comparison of the Incidence and Nature among Different Breeds and Populations of Minipigs.
abstract: Swine, especially the miniature swine or minipigs, are increasingly being used in preclinical safety assessment of small molecules, biopharmaceutical agents, and medical devices as an alternate nonrodent species. Although swine have been used extensively in biomedical research, there is a paucity of information in the current literature detailing the incidence of background lesions and differences in incidence between commonly used breeds. This article is a collaborative effort between multiple organizations to define and document lesions found in the common breeds of minipigs used for toxicological risk assessment in North America (NA) and the European Union (EU). We retrospectively assessed 10 years of historical control data from several institutions located in NA and EU, covering the period of 2004-2015. Here we report the background lesions with consideration of breed and geographical location. To our knowledge, this is the first report documenting spontaneous background lesions in commonly used breeds of swine in both NA and EU. This report serves as a resource to pathologists and will aid in interpretation of findings and differentiation of background from test article-related changes.
authors.affiliation: Medical University of South Carolina, Charleston, South Carolina, USA helke@musc.edu.
authors.forename: Kristi L
authors.initials: KL
authors.lastname: Helke
authors.affiliation: MPI Research, Mattawan, Michigan, USA.
authors.forename: Keith N
authors.initials: KN
authors.lastname: Nelson
authors.affiliation: Charles River Laboratories, Spencerville, Ohio, USA.
authors.forename: Aaron M
authors.initials: AM
authors.lastname: Sargeant
authors.affiliation: Charles River Laboratories, Spencerville, Ohio, USA.
authors.forename: Binod
authors.initials: B
authors.lastname: Jacob
authors.affiliation: Covance Laboratories Limited, Harrogate, North Yorkshire, UK.
authors.forename: Sean
authors.initials: S
authors.lastname: McKeag
authors.affiliation: CiToXLAB North America Inc., Laval, Quebec, Canada.
authors.forename: Julius
authors.initials: J
authors.lastname: Haruna
authors.affiliation: Huntingdon Life Sciences, East Millstone, New Jersey, USA.
authors.forename: Vimala
authors.initials: V
authors.lastname: Vemireddi
authors.affiliation: WIL Research, Ashland, Ohio, USA.
authors.forename: Melanie
authors.initials: M
authors.lastname: Greeley
authors.affiliation: Sinclair Research Center and Sinclair Bio Resources, Auxvasse, Missouri, USA.
authors.forename: Derek
authors.initials: D
authors.lastname: Brocksmith
authors.affiliation: Marshall BioResources, North Rose, New York, USA.
authors.forename: Nicole
authors.initials: N
authors.lastname: Navratil
authors.affiliation: Sinclair Research Center and Sinclair Bio Resources, Auxvasse, Missouri, USA.
authors.forename: Alain
authors.initials: A
authors.lastname: Stricker-Krongrad
authors.affiliation: MPI Research, Mattawan, Michigan, USA.
authors.forename: Charlotte
authors.initials: C
authors.lastname: Hollinger
mesh_terms: D000818:Animals; D035843:Biomedical Research / Q000458:organization & administration / Q000592:standards; D016208:Databases, Factual; D015994:Incidence; D013552:Swine; D013553:Swine Diseases / Q000145:classification / Q000453:epidemiology / Q000473:pathology; D013556:Swine, Miniature; D018675:Toxicity Tests / Q000592:standards
keywords: Göttingen; Hanford; Yucatan; background; minipig; pathology; spontaneous lesion; toxicology