Hodges, D., Tzafriri, R. Swine, the Other Tox Species.

Summary: Since 1937, the Food and Drug Administration (FDA) has required preclinical testing of new drugs and biologicals for pharmacologic activity and acute toxicity in animals prior to their use in clinical trials. The guidance established the use of two animal species, a rodent and a larger non-rodent mammal, for toxicological studies. However, acquiring dogs and non-human primates (NHPs) has become increasingly difficult and expensive, and their use may raise additional legal and ethical concerns. With the increasing costs of preclinical studies and the intensification of ethical concerns associated with the use of companion animals for scientific research, scientists are re-discovering alternative models such as pigs, rats and rabbits to better predict human toxicity.

Göttingen, Yucatan, and Yorkshire pigs are well established in surgical and physiological research. The pig has become the model of choice for FDA approval for the testing of surgical implants intended for human use. They have also been used for years in pharmacology and toxicology.

CBSET scientists have extensive experience with alternative large models such as sheep and swine for safety pharmacology studies and medical device testing, understand the specific advantages and challenges of these models and have developed unique methodologic know-how to answer complex biomedical questions.