Immunotoxicology

Immunotoxicology is the study of immune dysfunction resulting from exposure of an organism to a xenobiotic. The immune dysfunction may take the form of immunosuppression or alternatively, allergy, autoimmunity or any number of inflammatory-based diseases or pathologies. Because the immune system plays a critical role in host resistance to disease as well as in normal homeostasis of an organism, identification of immunotoxic risk is significant in the protection of human, animal and wildlife health. This guidance makes recommendations to sponsors of investigational new drugs (INDs) on the parameters that should be routinely assessed in toxicology studies to determine effects of a drug on immune function. When additional immunotoxicity studies should be conducted. When additional mechanistic information could help characterize the significance of a given drug’s effect on the immune system. This guidance is intended for drug products and does not apply to biological products. 

  • Immunosupression
  • Hypersensitivity
  • Autoimmunity
  • Adverse immunostimulation

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