Preclinical studies are laboratory and animal-based investigations conducted prior to human clinical trials to evaluate the safety, toxicology, pharmacokinetics (PK), pharmacodynamics (PD), and proof of concept of an investigational drug, biologic, or advanced therapy. They provide the scientific and regulatory justification required to support an Investigational New Drug (IND) or Clinical Trial Authorization (CTA) application, and must be conducted in accordance with Good Laboratory Practice (GLP) guidelines.
