Deputy Division Director US FDA Silver Spring, Maryland, United States
A complete safety assessment for any topically applied pharmaceutical should include an evaluation of its dermal sensitization potential. Traditional animal methods for evaluating dermal sensitization have included the murine local lymph node assay, the Buehler Test, and the guinea pig maximization assay. In addition, alternative non-animal methods have been developed that assess the biological processes leading to the immune response characteristic of dermal sensitization. Regardless of the method used, adequate dermal sensitization data should be included in the initial investigational new drug submission to the Food and Drug Administration (FDA). This presentation will include an evaluation of each method used to evaluate dermal sensitization and an overview of the Agency’s process in reviewing dermal sensitization data.
