Risk assessment for fetal toxicity

This paper reviews the problem of performing risk assessments using data on fetal toxic effects. It briefly discusses the usual dose-response models and their inappropriateness for application to such data. The paper then considers tests for determining whether the fetal toxic effect is increased over that of the control group. Assuming an increase has been shown, the use of a fetal toxicity, dose-response model for risk assessment is discussed. The paper then applies these methods to data from an experiment using female mice mated with irradiated males. Finally, the paper discusses the need for further statistical research in this important area.