Safety immunopharmacology: evaluation of the adverse potential of pharmaceuticals on the immune system.

Journal of Pharmacological and Toxicological Methods
Jacques Descotes

Abstract

The ICH S6R1 and S8 guidelines define a general framework for the immunotoxicity evaluation of biotechnology-derived pharmaceuticals and human pharmaceuticals, respectively. As severe and unpredicted adverse events dramatically showed in the recent years that the immune system is a critical aspect of drug safety, this framework needs to be revisited to enhance the prediction of nonclinical immune safety evaluation. Safety immunopharmacology is deemed to contribute to this awaited improvement by enabling early screening of the potential for drug candidates to induce unexpected immunosuppressive and immunostimulatory effects as well as nonimmune-mediated hypersensitivity reactions. Dedicated safety immunopharmacology can also generate mechanistic data to determine which relevant additional immunotoxicity studies should be conducted. Immunological assays and models that can be considered for use in the context of safety pharmacology studies are presented as well as perspectives for their timely development.

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Citations

Apr 15, 2014·British Journal of Pharmacology·A N Ilinskaya, M A Dobrovolskaia
Jun 2, 2015·Toxicology in Vitro : an International Journal Published in Association with BIBRA·Daniele CortiEmanuela Corsini
May 24, 2012·Journal of Pharmacological and Toxicological Methods·M K Pugsley, M J Curtis

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Methods Mentioned

BETA
transgenic
ELISA
flow cytometry

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