Miniature Swine in Nonclinical Safety Studies

This technical report discusses the role of miniature swine as a viable non-rodent species for nonclinical safety studies in drug development. It outlines the importance of species selection based on the type of test article and clinical indication, emphasizing that the choice is guided by regulatory documents and scientific considerations. The report details the physiological similarities between miniature swine and humans, particularly regarding metabolism and absorption, which support their use in various therapeutic areas. It also addresses the regulatory acceptance of miniature swine across multiple jurisdictions, including the U.S. and EU. The report presents case studies and real-world examples where miniature swine have been effectively utilized, highlighting their advantages over traditional non-rodent species like dogs and nonhuman primates. Additionally, it discusses the implications of size and the development of smaller variants, such as nanopigs, which facilitate their use in research. Overall, the report advocates for the inclusion of miniature swine in early species selection processes for both small and large molecule programs.