Journal Top Ten, COLUMNS-Drugs & Supplements, November 2004

1 ARTICLE: 'Regulatory immunotoxicology: does the published evidence support mandatory nonclinical immune function screening in drug development?'

SUMMARY: Recent immunotoxicity guidance documents from the EU CHMP and the US FDA apply significantly different weightings to immune function testing; whereas the former mandates (as a starting point) incorporation of immune function tests to screen for immunotoxic potential in sub-chronic rodent toxicity studies, the more cautious 'for cause' FDA approach recommends the use of IFTs only when warranted by evidence obtained from conventional nonclinical and/or clinical studies. Conclusions from detailed evaluations of several key drugs, including salmeterol and …