Nonclinical Safety Evaluations in Drug Development

• By: Paula J. Lapinskas, Ph.D
• Date: January 20, 2012

This article outlines key aspects of the overall drug development process with focus on the role of nonclinical safety evaluations at each stage of the development and also provides definitions of key terminology used in nonclinical toxicology. Three key decision points are addressed: Drug discovery (focus on lead optimization), nonclinical (or preclinical) safety evaluations prior to first-in-human studies and clinical development and nonclinical studies required for marketing decisions.