ABSTRACT

The advancement of disciplines such as metabolic pro¢ling and receptor interaction studies has changed the use of animal species in drug development. While previous use of animal species in safety assessment centred around the rat as the rodent species and the dog or non-human primate as the non-rodent species, pharmaceutical companies and regulatory agencies now acknowledge that species selection should be based on similarity to humans as far as is reasonably practicable. This includes pharmacokinetics and biotransformation and, when possible, responsiveness to the primary pharmacodynamic effects (CPMP/SWP/1042/99 2000).