Research topics in regulatory science: Developmental and reproductive toxicity of human pharmaceuticals

Abstract

In this review, I have discussed current issues related to risk assessments of developmental and reproductive toxicities during the use of pharmaceuticals in pregnant women or women of childbearing potential. Owing to the lack of empirical information on the use of pharmaceuticals (including those approved for the market) in pregnant women, the toxicity of these drugs has been generally evaluated in animal studies. In the case of embryo-fetal developmental (EFD) toxicity, in particular, testing of small-molecule pharmaceuticals in animals (namely rodents and rabbits) is required. The body of research in animal studies affords us an opportunity to explore numerous topics in regulatory science research. However, there are three major issues: risk communication, use of animals, and reduction or deferral of EFD toxicity studies for the development of human pharmaceuticals. Although regulatory science research may not be necessary for some topics, it would contribute to the reduction or replacement of testing in animals. It is hoped that regulatory science research in this field will proceed rapidly, with the goal of safe use of pharmaceuticals for women.