Immunotoxicology Evaluation of Investigational New Drugs. Guidance for Industry

Authors not specified. FDA, 2002. - 38 p.This guidance makes recommendations to sponsors of investigational new drugs 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, and 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.Contents:

Immunosuppression.
Detection of Immunosuppression.
Immune Function Studies.
Immune Cell Phenotyping.
Evaluating Signs of Immunosuppression.
Immunogenicity.
Hypersensitivity (Drug Allergy).
Type I.
Type II And III.
Type IV.
Pseudoallergic (Anaphylactoid) Reactions.
Autoimmunity.
Adverse Immunostimulation.
Safety Considerations.
Summary.Attachment: Flowchart For Determining When To Conduct Immunotoxicity Testing.