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.