Preclinical studies

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).

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U.S. Food and Drug Administration (FDA) The Drug Development Process Step 2: Preclinical research
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NCATS Toolkit for Patient-Focused Therapy Development: Preparation for Clinical Trials
NCATS Toolkit for Patient-Focused Therapy Development: Cell and Animal Models

Synonyms:
Preclinical research
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