Toxicological Research
- Volume 17
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- Pages.211-216
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- 2001
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- 1976-8257(pISSN)
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- 2234-2753(eISSN)
Immunotoxicology Evaluation of New Drugs
- Ahn, Chang-Ho (Office of Review Management, Center for Drug Evaluation and Research, United States Food and Drug Administration) ;
- Kenneth L. Hastings (Office of Review Management, Center for Drug Evaluation and Research, United States Food and Drug Administration)
- Published : 2001.07.01
Abstract
Drugs can have various adverse effects on the immune system including unintended immun-osuppression, induction of both drug-specific immune responses (including drug allergies) and non-specific immunostimulation (including autoimmune reactions), and direct activation of effector mechanisms (such as histamine release). As a practical matter, the Center for Drug Evaluation (CDER) relies on standard non-clinical toxicology studies to detect unintended immunosuppression. Specific assays using guinea pigs and mice are available to identify drugs that can induce immune-mediated dermal hypersensitivity reactions. Respiratory and systemic hypersensitivity and autoimmune reactions are more difficult to model in non-clinical studies. Unintended nonspecific immunstimulation can be detected in animal studies. CDER is currently developing specific guidance for evaluating potential drug immunotoxicity.