General Toxicology

The pharmacology studies (efficacy) most frequently consist of in vitro (cell line) and in vivo (animal) experiments that validate the potential desired effect of the new drug or test compound. This is often done in animal models that mimic human disease.

The toxicology studies (safety) evaluate the safety profile of the drug. This includes assessing effects on DNA (genotoxicity), critical organ systems like cardiovascular, respiratory, and central nervous systems (safety pharmacology), and general toxicity using rodent and non-rodent species.

Key Toxicology Studies:

• - Maximum Tolerable Dose (MTD)
• - Dose Range Finding (DRF)
• - Single Dose Toxicity Studies
• - Acute Studies
• - Repeated Dose Sub-Acute Toxicity Studies
• - Sub-Chronic and Chronic Toxicity Studies
• - Skin, Mucous Membrane, and Irritation Studies
• - Acute Oral Toxicity
• - Acute Dermal Toxicity Test
• - Dermal Irritation Test
• - Eye Irritation/Corrosion Test