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KMID : 0379520010170000211
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한국독성학회지
2001 Volume.17 No. 0 p.211 ~ p.216
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Immunotoxicology Evaluation of New Drugs
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Ahn Chang-Ho
Kenneth L. Hasthings
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Abstract
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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.
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KEYWORD
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Drug allergy, Immunosuppression, Immunotoxicology
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