The Value of Juvenile Animal Studies: A Pediatric Clinical Perspective

With the emphasis of US American and European legislators on consideration of children in the drug development process regulatory authorities ask increasingly for additional non-clinical data to elucidate the safety of a given drug in development in future pediatric use. Juvenile animal studies are increasingly requested. These requests should never be tick box requests. Companies, academic toxicologists, clinicians, and regulatory authorities need a dialogue to differentiate between the perceived need to do "something" and the request for studies that have clinically meaningful results. Birth Defects Res (Part B) 92:252-253, 2011. (C) 2011 Wiley-Liss, Inc.