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Non-Clinical Toxicology

Meaning

The comprehensive scientific discipline that assesses the potential for adverse health effects of a drug, hormone, or chemical substance in non-human biological systems, primarily through in vitro cell-based assays and in vivo animal studies, before human clinical trials commence. This essential pre-clinical phase establishes a preliminary safety profile, determines the maximum tolerated dose, and identifies potential target organ toxicities. It is a mandatory regulatory step in pharmaceutical and hormonal drug development.