Immunotoxicity safety testing

Safety of the product itself for the target organism, the user (who applies it) or the environment is addressed by a range of preclinical and clinical assessments which depend on the product and its use pattern. The range of safety features to be assessed includes local and systemic tolerance, acute and chronic toxicity, mutagenicity and tumorigenicity, reproductive toxicity, immunotoxicity and, for veterinary medicinal products, also the ecotoxicity. The safety tests will be described in more detail in a separate chapter below on preclinical pharmacological and safety test procedures. 

Developmental immunotoxicity testing has gained increasing attention with the recognition that for most drugs compared to date, when immunomodulatory effects are observed, the developing immune system is more sensitive than that of the adult. Therefore, safety limits for exposure of non-adults can be difficult to predict in the absence of age-relevant exposure assessment. 

Evans, E.W. (2008). Clinical pathology as crucial insight into immunotoxicity testing In Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk, D.J. Bussiere,... 

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