Immunotoxicology Evaluation of Investigational New Drugs. Guidance for Industry
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Description
Автор неизвестен. 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:Introduction.Background.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.References.Attachment: Flowchart For Determining When To Conduct Immunotoxicity Testing.
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