Several key toxicological studies are essential in an NDA, including:
- Acute Toxicity Studies: These evaluate the adverse effects that occur shortly after a single dose or multiple doses within 24 hours. They help in determining the lethal dose (LD50) and the initial safe dosage for humans.
- Chronic Toxicity Studies: Conducted over a longer period, these studies assess the effects of prolonged exposure to the drug. They are crucial for understanding the potential for chronic toxic effects, such as organ toxicity or carcinogenesis.
- Reproductive and Developmental Toxicity Studies: These assess the potential impact of the drug on reproduction and development, including effects on fertility, embryonic development, and teratogenicity.
- Genotoxicity Studies: These evaluate the potential of a drug to cause genetic damage, which could lead to cancer or heritable genetic mutations.
