The Use of Göttingen Minipigs in Juvenile Studies

Translational animal models are essential for understanding human development and diseases, and for developing safe and efficacious human medicines and vaccines. Over the last decades, the use of minipigs and especially Göttingen Minipigs has emerged as an animal model in preclinical safety testing of small-molecule drugs and for pharmacological research within various disease and therapeutic areas such as cardiometabolic diseases and pain management, but also for vaccine development. Today, a pediatric assessment is required by regulatory authorities for all new drug applications and for food intended for infants below 16 weeks of age. Guidelines and recommendations for such juvenile studies have been published by regulatory authorities including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Food Safety Authority (EFSA). Those guidelines all recommend considering minipigs and highlight the many similar developmental milestones between minipigs and man, the large litter size allowing balanced sex distribution and cross-fostering, the relatively large size at birth, and easy handling including easiness of all routes of administration, and further state that the minipig may be a more appropriate model than other species when there are differences in drug metabolism between the human and other laboratory animal species. Finally, the EFSA scientific opinion highlights that (pre)term piglets are a relevant animal model for the safety evaluation of food additives, pesticide residues, and contaminants present in food on general toxicity parameters and postnatal development and maturation of various organ systems.