US EPA

624893 

Journal Article 

Assessing immunotoxicity: guidelines 

Putman, E; van der Laan, JW; van Loveren, H 

2003 

Yes 

Fundamental and Clinical Pharmacology
ISSN: 0767-3981
EISSN: 1472-8206 

17 

5 

615-626 

10.1046/j.1472-8206.2003.00181.x 

WOS:000185959200011 

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, druginduced 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. 

autoimmunity; developmental immunity; hypersensitivity;
immunotoxicity; photosensitivity; predictability; regulatory guidelines