This module provides an overview of the requirements for non-clinical safety profiling of an investigational drug. Links to relevant ICH guidelines are provided at the end of the module.

Non-clinical safety (also called toxicology) is an essential discipline in drug development. It plays a pivotal role in assessing the potential risks and ensuring the safety of new pharmaceutical compounds. The fundamental principles of non-clinical safety in drug development, emphasizing its importance, methodologies, and regulatory implications are summarized here.