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This core reference explains current strategies for immunotoxicology pharmaceutical safety assessments, which can reduce drug candidate attrition and streamline the development process. This guide thoroughly covers the testing needed to detect and characterize low-level immunotoxic hazards: 1) immunochemistry to address immunogenicity of biopharmaceuticals; 2) molecular immunology to evaluate immune dysregulation at the subcellular level; and 3) in vivo models of immune disorders to characterize potential impairment of host defense to infections, tumors, and autoimmune diseases. This is a key resource for practicing toxicologists and scientists involved in drug development or regulation.