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The field of immunotoxicology has been growing rapidly and a wide variety of immunotoxicity testing methods is now available. This chapter first discusses approaches to developing immunotoxicity testing strategies and provides a general overview of the types of assays currently available and how they are used. These assays are classified either according to the type of immune response being measured, the experimental design, or the number of immune cell types involved. The chapter then focuses on in vitro and ex vivo assays used during drug development that have been developed more recently, rather than on the more established immunotoxicity assays (e.g., in vivo T-dependent antibody response). These assays address concerns regarding hypersensitivity reactions, immunoenhancement and immunosuppression. Assays for hypersensitivity include measuring human mast-cell function and activation of the complement cascade, while those for immunoenhancement include the cytokine release assay. Immunosuppression can be measured using assays that use co-cultures of different types of immune cells, such as the human lymphocyte activation assay, three-dimensional culture systems, and by assays that measure T-cell function. Several of the assays presented are in vitro assays that use human immune cells to enhance the translatability to human risk. In addition, assays that can be added to standard toxicology studies are discussed.

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