Validation of Alternative Tests for Developmental and Reproductive Toxicology Testing: An ILSI Health and Environmental Sciences Institute Perspective

The current political and societal climate is driving the science of toxicology towards developing non-animal testing methodologies. Though alternative and in vitro tests have always been a mainstay for toxicological testing, technological advances in the last decade have allowed toxicologists to move rapidly towards a better understanding of the relevance of in vitro endpoints for traditional apical endpoints. Non-animal research using new technologies have illuminated toxicologists on the mechanisms of protection and adverse health outcomes. In this context, the “validation” of alternative and in vitro tests has taken on significant importance, particularly in regard to satisfying safety concerns of drugs and chemicals in a regulatory setting. The purpose of this chapter is to briefly review the impetus for the development of alternative and in vitro tests, discuss the projects underway at the ILSI Health and Environmental Sciences Institute (HESI) that are oriented towards this topic, and summarize the processes for formal validation. It should be noted that though there are validated assays and tests, these are under constant evaluation by scientific researchers as our understanding of the underlying biological processes continues to evolve.