The Duff Report
"Most, if not all, new medicines arise from biological insights gained from well-designed animal studies. Important information can be learned about the intended pharmacological response of a new medicine, and its potential for adverse reactions, from studies in animal models.
"Animal studies taking due regard of the three ‘Rs’ remain necessary for many aspects of pre-clinical development of novel agents including testing of ‘off-target’ and ‘on-target’ toxicity and understanding the fundamental biology relevant to a new medicine and its target molecules in the human. The key point we want to make is the importance of deciding what can be learned from animal studies in the pre-clinical development of a new medicine, and what limitations there might be when it comes to predicting the response, and dose-response relationship, in humans."