The safety evaluation of immunomodulators involves rigorous preclinical and clinical testing. Toxicologists assess various parameters, including:
Dose-Response Relationship: Determining the range between effective and toxic doses to establish a therapeutic window. Immunotoxicity Testing: Evaluating effects on immune cell populations, cytokine production, and potential for inducing hypersensitivity or autoimmune reactions. Long-term Studies: Conducting studies to assess the risk of carcinogenicity and chronic toxicity over extended periods.
