Nonclinical Support of Pediatric Drug Development in a Global Context: An Industry Perspective

The earlier inclusion of children into clinical trials has challenged toxicologists to develop nonclinical strategies to support these trials early in the drug development process, and the routine practise of global development strategies (i.e., concomitant development and filing in multiple geographical regions) adds another complication. Ideally, one would like to develop a stagey that would meet regulatory requirements from all regions. This presentation illustrated the challenges faced in developing a strategy regarding the need to perform a toxicity study in juvenile animals and the design of any necessary study that will receive global regulatory agreement. Birth Defects Res (Part B) 92:269-272, 2011. (C) 2011 Wiley-Liss, Inc.