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Nonclinical Toxicology

Meaning

Nonclinical Toxicology is the comprehensive scientific discipline dedicated to studying the adverse effects of a new drug, such as a hormone or peptide therapeutic, on living organisms prior to its administration in human clinical trials. This mandatory regulatory phase uses in vitro and in vivo studies, primarily in animal models, to identify potential toxicities, determine safe starting doses for humans, and characterize the drug’s safety profile. It forms the foundational safety data that must be submitted to regulatory bodies like the FDA and EMA before an Investigational New Drug application can be approved. The goal is to predict and mitigate risks to human health.