NEUROBEHAVIORAL ASPECTS OF DEVELOPMENTAL TOXICITY TESTING

Tests for detection of neurobehavioral changes in the offspring have b een a regulatory requirement in developmental toxicity testing of drug s for almost 20 years. Keeping their purpose of hazard identification and risk assessment for humans in mind, investigators and agency revie wers have become deeply ingrained with some stereotyped behaviors with respect to such relevant issues as choice of animal species and data evaluation. Other problematic areas of study design and conduct, selec tion of litter representatives for testing, what methods to combine in a resting battery, and statistical treatment of results and their int erpretation, will need more research and discussion in the future.