ABSTRACT
The principal goals of nonclinical safety testing of pharmaceuticals are to enable the
intentional exposure of humans to test compounds and to demonstrate that a proposed drug
product is reasonably safe for its intended use. These studies are conducted to determine
whether a candidate pharmaceutical can be safely administered to humans and the
conditions under which intentional exposure does not present unreasonable risk.
Additional goals of toxicology studies with pharmaceuticals are hazard identification
(determining the toxic potential of a test compound) and risk assessment (determining the
conditions of exposure, including dose, duration, and route) that may produce adverse
effects in humans.
