Safety Assessment Studies: Immunotoxicity

The clinical shift from immunology to toxicology resulted in the introduction of toxicological concepts in immunotoxicity evaluation. Current procedures for assessing the immunotoxicological safety of medicinal products have some shortcomings. Nonclinical immunotoxicity evaluation is currently limited to unintended immunosuppression. This article discusses various safety factors related to immunotoxicity, including preclinical assessment of immunosuppression and models of IgE mediated hypersensitivity reactions. Keywords: immunotoxicity; toxicology; immunosuppression; IgE-mediated hypersensitivity; drug safety