(Previously offered as 461.2)
Dr. Williams and Staff
An introduction to all aspects of biological safety evaluation of chemicals prior to clinical trials with emphasis on regulatory considerations including: acute, subacute and chronic toxicity in small and large laboratory animals; reproductive performance and teratology in rodents and lagomorphs; in vitro and in vivo mutagenicity assays; special toxicities and their mechanisms as they bear on regulatory decision-making; comparative toxicokinetics.
Prerequisites: M.D., Ph.D., D.V.M. or permission of instructor.
Lecture: 30 hrs. Pass/Fail