Preclinical studies are investigations that test a drug, procedure, or medical treatment in cell and/or animal models to determine any toxic effects before trials can be carried out in humans. Cell and animal model studies support Phase 1 safety and tolerance studies and must comply with good laboratory practice (GLP). Data about a drug’s activities and effects in animals help establish boundaries for safe use of the drug in subsequent human testing (clinical trials).
U.S. Food and Drug Administration (FDA) The Drug Development Process Step 2: Preclinical research
NCATS Toolkit for Patient-Focused Therapy Development: Preparation for Clinical Trials
NCATS Toolkit for Patient-Focused Therapy Development: Cell and Animal Models