ABSTRACT
This chapter presents practical methods of testing used in performing female reproductive and developmental toxicity studies, as well as approaches for interpreting the test results in a risk assessment context. The evaluation methods presented are those used in studies conducted for regulatory use, that is, in the process of identifying the safety of both small and large (biologic) molecule pharmaceuticals, chemicals, pesticides, fungicides, direct and indirect food additives, and medical devices. The methods described in this chapter deal mainly with in vivo tests conducted for regulatory use in standard laboratory species and touch only brie¦y on in vitro and in vivo methods used for screening agents and identi•cation of the mechanism or mode of action. Test methods used to evaluate reproductive toxicity in male animals, as well as in depth in vitro methods used to evaluate development, genomic methodology, and in vivo behavioral/functional parameters, are addressed elsewhere in this book.
