Several key toxicology studies are necessary for an IND, including:
Acute Toxicity Studies: Assess the effects of a single dose to understand the drug's immediate toxicity. Subchronic and Chronic Toxicity Studies: Evaluate the effects of repeated dosing over a longer period to identify cumulative toxicity. Carcinogenicity Studies: Determine if the drug has the potential to cause cancer, particularly for drugs intended for long-term use. Reproductive and Developmental Toxicity Studies: Investigate the drug's effects on fertility, embryonic development, and potential teratogenic risks. Genotoxicity Studies: Assess the drug's potential to cause genetic damage.
