The Chemoprevention Branch of the Division of Cancer Prevention and Control at the National Center Institute directs a program to identify and develop drugs for human use that will prevent, delay, or reverse the progression of cellular dysplasia (e.g. intraepithelial neoplasia) to invasive cancer. Part of the drug research and development process involves preclinical toxicology studies. These studies are performed under Good Laboratory Practices according to guidance documents published by the Food and Drug Administration and are used to support Investigational New Drug application and eventually New Drug Applications to the FDA for the marketing approval of cancer chemopreventive agents. The contractor shall complete four (4) developmental, teratology Segment II evaluations in both rats and rabbits within 2 years of contract award. The compound to e evaluated will be specified by the NCI. A range finding and a definitive test shall be conducted for each species. Evaluation shall include material and fetal toxicities and visceral and skeletal fetal malformations.
