Introduction to the immune system and adverse modulation activities of drugs

1 Introduction to the immune system and adverse modulation activities of drugs 

Exclusion from such listing was due to the planned implementation of a specific guidance on the evaluation of immunotoxicology of new drugs—ICH S8 [1], not implemented, however, until 2005. 

The immune system was (and still is) listed as a secondary organ system for safety pharmacology evaluation in S7A [2], In this context, it is presented here. 

Although the types of immunological responses to various therapeutics may be similar, the approach taken for screening potential immunological activity will vary depending on the route of administration of the compound. Pharmaceuticals are developed with intentional but restricted 

PCA evaluation is a screen for a form of potential immune stimulation and can be performed using mice, rats, or guinea pigs (historically, primates have also been used). 

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