title: Assessing immunotoxicity: guidelines.
abstract: Over the last couple of years the assessment of immunotoxic potential of human pharmaceuticals has drawn considerable attention worldwide. Regulatory agencies entrusted with the registration of pharmaceuticals (or other compounds) found an increased need for guidance on this issue. This has resulted in the release of guidance documents on immunotoxicity in Europe, USA and Japan in close succession. In Europe the CPMP has released their immunotoxicity guidance documents that are now in force. The FDA and the Japanese Authorities are in the process of doing so, and will shortly enforce them. Immune suppression and stimulation, hypersensitivity, photosensitivity, drug-induced autoimmunity and developmental immunotoxicity are the focus of regulatory testing. This review discusses these kinds of immunotoxicity and their clinical implications. The three regional guidelines and screening tools for detection are discussed. Additionally, the scientific background on which these guidelines are based is briefly highlighted.
authors.affiliation: Preclinical Assessment Group of the Medicines Evaluation Board, Laboratory for Medicines and Medical Devices, National Institute for Public Health and the Environment, Bilthoven, The Netherlands.
authors.forename: E
authors.initials: E
authors.lastname: Putman
authors.forename: J W
authors.initials: JW
authors.lastname: van der Laan
authors.forename: H
authors.initials: H
authors.lastname: van Loveren
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects; D032761:Animal Experimentation / Q000592:standards; D000818:Animals; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007107:Immune System / Q000187:drug effects*; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects*; D017410:Practice Guidelines as Topic; D013678:Technology, Pharmaceutical / Q000592:standards*
chemical_list: D000276:Adjuvants, Immunologic; D007166:Immunosuppressive Agents