Models for Preclinical Testing of Allergy
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0092-8615/97 Copyright 0 1997 Drug Information Association Inc.
MODELS FOR PRECLINICAL TESTING OF ALLERGY KLAUS
EJNERANDERSEN, MD
Department of Dermatology, Odense University Hospital, Odense, Denmark
Hypersensitivity reactions to drugs are a common clinical problem, for which it is difficult, howevel; to establish the causative mechanism. Some of the reactions are of the allergic nature. Animal models have been succesfully developed by using classical immune endpoints. Animal models have been succesfully developed to detect human airway sensitizers by using classical immune endpoints. They are not, however, validated and standardized to a degree which would give them a predictive value. Regarding contact allergy several animal assays are described which reliably identify substances which can cause allergic contact dermatitis. A number of guinea pig methods are available with their advantages and disadvantages. An overview of current methods is given. Predictive allergy test results cannot stand alone and should be interpreted with care. They are important tools, howevel; for safe development of new chemicals for topical use when the tests are executed and interpreted by trained people. Their value in the development of pharmaceuticals is less well documented. Key Words: Allergenicity; Guinea pig models; Pharmaceuticals; Validation
INTRODUCTION HYPERSENSITIVITY REACTIONS TO drugs are a common clinical problem. In many cases, however, it is difficult to establish the mechanism behind the hypersensitivity. Some of the reactions are of an allergic nature-proven by the presence of specific IgE in the case of immediate reactions, or by a specific delayed response to a challenge in the case of more protracted reactions from the skin or other target organs. With regard
Presented at the DIA Workshop “Immunotoxicity of Pharmaceuticals: Current Knowledge, Testing Strategies, Risk Evaluation, and Consequences for Human Health,” October 2 4 , 1996, Montreux, Switzerland. Reprint address: Prof. Dr. med. K. Andersen, Department of Dermatology, Odense University Hospital, DK5000, Odense, Denmark.
to predictive allergy tests there is no reliable in vitro assay available. The immunological mechanism behind allergy is very complex and allergy requires a complete individual (animal or man) to develop. Animal models have been succesfully developed to detect human airway sensitizers by using classical immune endpoints. They are not, however, validated and standardized to a degree which would give them a predictive value. Regarding contact allergy several animal assays are described which reliably identify substances which can cause allergic contact dermatitis. The methods have been developed over the last 40 years and much experience has been gained. The methods have reached a standard where they are included in official guidelines. These methods may perhaps also be useful in the process of eval-
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Klaus Ejner Andersen
TABLE 1 Guinea Pig Allergy Tests
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