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What are the prospects for regulation in immunotoxicology?
1Division of Special Pathogen and Immunologic Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD 20857, USA. hastingsk@cder.fda.gov
Abstract:
Evaluating the immunotoxic potential of investigational new drugs is a standard component of non-clinical safety assessment. Effects evaluated include the potential for drugs to induce hypersensitivity and/or autoimmune reactions or to produce unintended immunosuppression. The Center for Drug Evaluation and Research (CDER) is considering approaches for evaluating potential immunotoxicity. In particular, two methods are being examined for potential recommendation where indicated: immune cell phenotype determination and the murine local lymph node assay. Issues concerning immunotoxicology testing will be discussed.