Changing the field of carcinogenicity testing of human pharmaceuticals by emphasizing mode of action

Lifetime testing for carcinogenicity of pharmaceuticals in rodents has been a controversial issue since the start of the International Conference on Harmonisation in 1990. Since 2010 the debate reached a new level following the proposal that a negative outcome of carcinogenicity studies can be predicted based upon the findings of 6 months studies. In addition, the value of pharmacological mode of action (MoA) data for positive prediction has become apparent.