Toxicology is integral to the NDA process as it evaluates the safety of the drug for human use. It involves the study of the adverse effects of chemicals, including drugs, on living organisms. In an NDA, toxicological data provides evidence on the potential toxic effects of a drug, helping to identify the acceptable dosage levels and the conditions under which the drug can be used safely. This data is gathered from preclinical studies usually conducted on animal models to predict how the drug might affect humans.
