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

Publication Year: 2012

Edition: 1st

Authors/Editor: Hoberman, Alan M.;, Lewis, Elise M.

Publisher: Wiley

ISBN: 978-0-47-044861-8

Doody's Star Rating®: Score: 99

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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.


Platform: Ovid
Publisher: Wiley
Product Type: Book
Author/Editor: Hoberman, Alan M.;, Lewis, Elise M.
ISBN: 978-0-47-044861-8
Pharmaceutical Science
Language: English
Edition: 1st
Pages: 356
Year: 2012
Doody's Star Rating®: Score: 99