The Use of Minipigs in Non-Clinical Research

The choice of animal species in relation to non-clinical research should always be carefully considered and justified. Pigs and minipigs are considered good models for humans because they share some important characteristics with man. Swine exhibit particularly close resemblance to humans with respect to the anatomy of the skin, the cardiovascular system, the major part of the gastrointestinal tract, the nasal cavity, and the urogenital system. In addition, similarities are often found regarding metabolism of drugs and physiological parameters in these two species. In drug development, the intended clinical route of dosing should always be applied in non-clinical studies wherever possible. All general routes of product administration (i.e. dermal [topical and intradermal], intramuscular and intravenous, oral and subcutaneous) are practically feasible in pigs and minipigs. Furthermore, all generally required durations of dosing can be completed, with up to 12 months of daily dosing, depending on the route of dose administration. For regulatory toxicity studies, the minipig in particular should always be considered as a relevant test species. Indeed, the minipig is fully accepted by regulatory authorities worldwide.