Pediatric Non-Clinical Drug Testing Principles, Requirements, and Practice

After more than forty years, ethical, political, and practical concerns continue to plague pediatric testing and labeling. This book explores ways to meet FDA guidelines for non-clinical testing, differences resulting from new EMEA legislation, and how to develop appropriate information for submission to both agencies, while providing practical study designs and approaches that can be used to adhere to international requirements. Meeting a critical need, Pediatric Non-Clinical Drug Testing delivers real solutions to traverse the regulatory maze associated with this field of research. A must for toxicologists and pharmacokinetics personnel working in industrial, academic and clinical settings as well as regulatory affairs personnel and physicians.

Alan M. Hoberman, PhD, DABT, Fellow ATS, is Executive Director of Site Operations and Toxicology at Charles River Preclinical Services, Horsham, PA. Elise M. Lewis, PhD, is Director of Reproductive and Neurobehavioral Toxicology at Charles River Preclinical Services, Horsham, PA.