|
1000
|
Abstract/Summary
|
-
The global regulatory requirements for the assessment of the
carcinogenic potential of pharmaceuticals provided for the conduct
of long-term carcinogenicity studies in two rodent species, usually
the rat and the mouse. Given the their extensive use of animals
as well as the costs of these studies, it is in keeping with the
mission of International Council on Harmonization of Technical
Requirements of Pharmaceuticals for Human Use (ICH) to
examine whether this practice requiring long-term carcinogenicity
studies in two species could be reduced without compromising
human safety.
|
