ABSTRACT
The principal subject of this chapter is the presentation of practical methods used in performing reproductive (female) and developmental toxicity studies. In general, the methods reported are those used in studies conducted for regulatory use-that is, in the process of identifying the safe use of pharmaceuticals (including small molecules and biologics), chemicals, pesticides, fungicides, direct and indirect food additives, and devices. Although many additional
in vitro
and elegant
in vivo
methods exist for screening agents and to identify mechanisms, the methods described in this chapter are generally limited to
in vivo
tests conducted for regulatory use in standard laboratory species. Tests used to evaluate reproductive toxicity in male animals are addressed elsewhere in this book, as are
in vitro
methods used to evaluate development, genomic methodology, and
in vivo
behavioral and functional tests. Mechanistic studies employing biotechnology techniques and methods for identifying the pharmacodynamics and kinetics of specific exposures are alluded to but are also described in detail in other chapters.