Drug administration during pregnancy-evaluation of fetal toxicity: animal studies

Teratological investigations on mammalian fetuses really began in the 1930s. Before the thalidomide tragedy, there was no compelling reason to develop tests for pregnant animals, because the medical profession thought them unnecessary [1]. Since 1994, reproductive toxicology studies must be performed according to harmonised ICH (International Conference on Harmonisation) guidelines, which are the reference for new compound registration [2]. The primary objective should be to detect any indication of embryo-fetal toxicity in laboratory animals and then to conduct a human risk assessment.