Author : Alan M. Hoberman
Publisher : John Wiley & Sons
ISBN 13 : 1118168259
Total Pages : 333 pages
Book Rating : 4.1/5 (181 download)
Book Synopsis Pediatric Non-Clinical Drug Testing by : Alan M. Hoberman
Download or read book Pediatric Non-Clinical Drug Testing written by Alan M. Hoberman and published by John Wiley & Sons. This book was released on 2011-12-28 with total page 333 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explains the importance and practice of pediatric drug testing for pharmaceutical and toxicology professionals. It describes the practical and ethical issues regarding non-clinical testing to meet US FDA Guidelines, differences resulting from the new European EMEA legislation, and how to develop appropriate information for submission to both agencies. It also provides practical study designs and approaches that can be used to meet international requirements. Covering the full scope of non-clinical testing, regulations, models, practice, and relation to clinical trials, this text offers a comprehensive and up-to-date resource.