Miniature Swine Breeds in Toxicology and Drug Safety Assessments: What to Expect during Clinical and Pathology Evaluations
Abstract
The use of miniature swine as a nonrodent species in safety assessment has continued to expand for over a decade, and they are becoming routinely used in toxicology and in pharmacology as well as a model for human diseases. Miniature swine models are regularly used for regulatory toxicity studies designed to assess safety of new therapeutic compounds given through different routes of exposure and are used as an alternative model to the canine or the nonhuman primate. Translational preclinical swine study data presented support the current finding that miniature swine are the animal model of choice for assessment of drug absorption, tolerance, and systemic toxicity following systemic exposures. Because research investigators need to be familiar with important anatomic and histopathologic features of the miniature swine in order to place toxicopathologic findings in their proper perspective, clinical and anatomic pathology data from a large number of Sinclair, Hanford, Yucatan, and Göttingen breeds from control groups from a wide variety of studies performed between 2004 and 2014 will be presented, compared, and partially illustrated.
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Minipig skin most closely resembles human skin, with similar thicknesses of various layers and hair follicle density.
“In recent years, general toxicity studies and irritation evaluations have been conducted using minipigs, whose skin most closely resembles human skin, with similar thicknesses of various layers and hair follicle density6, 7, 8.”
From Morphological characteristics and notes of the skin in preclinical toxicity assessment (2023) · cites this paper as [7]
The Conclusion (page unavailable) identifies the integumentary system as a similarity between miniature swine and humans, and the Discussion notes their use in dermal toxicity studies. Our copy does not say minipig skin is the closest match to human skin or give comparisons of skin-layer thickness or hair follicle density. (LLM, conf=0.86)
Experimental — accuracy not yet measuredErythema and edema have recently been evaluated in repeated dermal administration toxicity studies using minipigs rather than solely in irritation studies.
“However, erythema and edema have recently been evaluated in repeated dermal administration toxicity studies using minipigs rather than solely in irritation studies7.”
From Morphological characteristics and notes of the skin in preclinical toxicity assessment (2023) · cites this paper as [7]
The Discussion says Hanford minipigs have been used for regulatory dermal toxicity studies, and the Conclusion lists both repeat-dose studies and dermal administration among minipig applications (page numbers unavailable). Neither passage says erythema and edema were evaluated in repeated dermal administration studies or contrasts those studies with irritation studies. (LLM, conf=0.82)
Experimental — accuracy not yet measuredThe density of hair follicles varies with species, with higher follicle densities in rodents and lower densities in humans, monkeys, and minipigs.
“The density of hair follicles varies with species, with higher follicle densities in rodents and lower densities in humans, monkeys, and minipigs7, 9.”
From Morphological characteristics and notes of the skin in preclinical toxicity assessment (2023) · cites this paper as [7]
The Conclusion (page unavailable) mentions similarities between miniature swine and humans in the integumentary system, but does not discuss hair-follicle density. Searches of our copy for hair follicles and follicle density found no comparison among rodents, humans, monkeys, and minipigs. (LLM, conf=0.72)
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Research works printed but not linked: 3
- Dincer, Z., Gad, S. C., Skaanild, M. T., and Svendsen, O. (2007). The minipig. In Animal Models in Toxicology (S. C. Gad, ed.), 2nd ed., pp. 731-71. CRC Press, Boca Raton, FL.
- Gad, S. C., Stricker-Krongrad, A., and Skaanild, M. T. (2015). The minipig. In Animal Models in Toxicology (S. C. Gad, ed.), 3rd ed., pp. 76-808. CRC Press, Boca Raton, FL.
- Leary, S.U., Underwood, W., Anthony, R., Cartner, S., Corey, D., Grandin, T., Greenacre, C., Gwaltney-Brant, S., McCrackin, M.A., Meyer, R., Miller, D., Shearer, J., and Yanong, R. (2013). AVMA Guidelines for the Euthanasia of Animals: 2013 Edition, pp. 47-58.
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Morphological characteristics and notes of the skin in preclinical toxicity assessment
Moroki, T. (2023) · Journal of Toxicologic Pathology · doi:10.1293/tox.2022-0103 · Cited by 26 · see citing works
- Authors
- Stricker-Krongrad, A., Shoemake, C. R., Pereira, M. E., Gad, S. C., Brocksmith, D., & Bouchard, G. F.
- Affiliations
- Sinclair Research Center, Columbia, Missouri, USA
- HSRL, Inc., Mount Jackson, Virginia, USA
- Gad Consulting Services (United States) (US)
- Missouri Southern State University (US)
- Corresponding author
- Shoemake, Catherine R.
- ORCID
- Gad, Shayne C.
- Venue
- Toxicologic Pathology
- Publisher
- SAGE Publications
- Published
- 2015-12-10
- Volume
- 44
- Issue
- 3
- Pages
- 421-427
- ISSN
- 0192-6233 (ISSN-L)
- 1533-1601
- OpenAlex
- W2191431071
- Cited by
- 29
- References
- 0
- Citations by year
- 2026: 3 · 2025: 1 · 2024: 3 · 2023: 2 · 2022: 4 · 2021: 5 · 2020: 2 · 2019: 3 · 2018: 1 · 2017: 3 · 2016: 2
- FWCI
- 3.22
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Toxicologic Pathology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Veterinary › Small Animals › Animal testing and alternatives
- Life Sciences › Immunology and Microbiology › Immunology › Immunotoxicology and immune responses
- Health Sciences › Veterinary › Small Animals › Veterinary Pharmacology and Anesthesia
- Keywords
- miniature swine, drug safety assessment, translational animal model, systemic toxicity, drug absorption, pathological anatomy, histopathology
- MeSH terms
- Animals, Drug Evaluation, Preclinical, Female, Histocytochemistry, Male, Swine, Swine, Miniature, Toxicity Tests, Models, Animal
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