Sinclair Nanopig as a Non-Rodent Model in Drug Development

This technical report discusses the suitability of the Sinclair Nanopig™ as a non-rodent model for preclinical drug development. It outlines the advantages of using miniature swine, particularly the Sinclair Nanopig™, which has been shown to be a cost-effective alternative to traditional canine models. The report details the anatomical and physiological similarities of the Sinclair Nanopig™ to humans, which enhance its relevance in safety pharmacology and toxicology studies. It presents findings on test article usage, demonstrating that the Sinclair Nanopig™ requires less test article compared to canines, especially in studies lasting under six months. The report also reviews a case study where the Sinclair Nanopig™ was utilized to reduce emesis in a preclinical study, highlighting its practical benefits. Additionally, it discusses regulatory acceptance based on ICH M3 (R2) guidelines, emphasizing the growing industry trend towards adopting this model for drug safety assessments. Overall, the report supports the Sinclair Nanopig™ as a viable option for advancing drug development processes.