International – ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals Step5

Historically, the regulatory requirements for the assessment of the carcinogenic potential of
pharmaceuticals in the three regions (E.U., Japan, U.S.) provided for the conduct of long-term carcinogenicity studies in two rodent species, usually the rat and the mouse. Given the cost of these studies and their extensive use of animals, it is in keeping with the mission of ICH to examine whether this practice requiring long term carcinogenicity studies in two species could be reduced without compromising human safety…