What Are the Key Components of Nonclinical Evaluation?
The key components of nonclinical evaluation for anticancer pharmaceuticals include:
Toxicology Studies: These studies assess the potential harmful effects of the drug on various organs and tissues. Acute, sub-chronic, and chronic toxicity studies are typically conducted in different animal species. Pharmacokinetics and Pharmacodynamics: These studies evaluate how the drug is absorbed, distributed, metabolized, and excreted (ADME) in the body, as well as its biological effects and mechanism of action. Efficacy Studies: In vivo models, such as xenograft or genetically engineered mouse models, are used to assess the anticancer activity of the drug. Genotoxicity and Carcinogenicity Studies: These tests determine whether the drug has the potential to cause genetic mutations or cancer in the long term.
