Developmental and Reproductive Toxicity Studies (DART) (GLP and Non-GLP)

Reproductive toxicity studies are designed to investigate the affect of a test article on male and female fertility and reproductive performance, estrous, spermatogenesis, implantation, embryo-fetal survival and development, gestation length, parturition, lactation, pup survival and development (including potential functional and behavioral effects), and the ability of offspring from the exposed parental generation to reproduce normally.  Non-GLP pilot studies are conducted to provide data needed to determine dose levels for definitive studies.  Pilot and embryo-fetal development studies are usually conducted in rats and rabbits.  Fertility and reproductive performance, and pre and postnatal development studies are usually conducted in rats or mice. Mice or dogs can also be used when necessary for embryo-fetal development studies.