Miniature Swine Use in Toxicology Studies

Over the last few decades the miniature swine has emerged as an important species in regulatory toxicology studies to assess toxicity of primarily small molecules. Several publications exist describing the anatomy, physiology as well as the translational value of the miniature swine compared to humans. Many miniature swine breeds exist, each has different properties and suitability in pharmacology studies, however in regulatory toxicology, the Göttingen Minipig, is the most commonly used miniature swine breed. The regulatory authorities, Food and Drug Administration (FDA) as well as the European Medicines Agency (EMA), require safety testing of pharmaceuticals and medical devices prior to human use. The miniature swine is a suitable model for studies within general, juvenile, and reproductive toxicology as well as within safety pharmacology and can be used for toxicity studies described in the guidance set forth by the International Conference for Harmonisation (ICH). The practical implications and challenges in using miniature swine are described in the current chapter, and gives an overview of routes of administration, procedures, and common background findings associated with regulatory toxicology studies.