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Alan M. Hoberman - Pediatric Non-Clinical Drug Testing: Principles, Requirements, and Practice - 9780470448618 - V9780470448618
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Pediatric Non-Clinical Drug Testing: Principles, Requirements, and Practice

€ 164.24
FREE Delivery in Ireland
Description for Pediatric Non-Clinical Drug Testing: Principles, Requirements, and Practice Hardcover. This book explains the importance and practice of pediatric drug testing for pharmaceutical and toxicology professionals. Editor(s): Hoberman, Alan M.; Lewis, Elise M. Num Pages: 356 pages, Illustrations. BIC Classification: MJ; MM; PN. Category: (P) Professional & Vocational. Dimension: 162 x 241 x 28. Weight in Grams: 708.
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.

Product Details

Format
Hardback
Publication date
2012
Publisher
John Wiley & Sons Inc United Kingdom
Number of pages
356
Condition
New
Number of Pages
384
Place of Publication
New York, United States
ISBN
9780470448618
SKU
V9780470448618
Shipping Time
Usually ships in 7 to 11 working days
Ref
99-50

About Alan M. Hoberman
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.

Reviews for Pediatric Non-Clinical Drug Testing: Principles, Requirements, and Practice
“Overall, this is a very useful book in bringing together many of the aspects associated with JA toxicology testing of pharmaceuticals for the first time, especially for those new to this growing field, with the chapters on study design considerations being especially useful.”  (British Toxicology Society New, 1 November 2012) “The book is an essential reference for international regulatory personnel, toxicologists, pharmacokineticists, scientists working in the pharmaceutical industry, academics and physicians and pharmacists concerned about the safe use of medicines in children.”  (Pharmaceutical Journal, 11 September 2012) “No other single resource combines pediatric drug development considerations with the most recent regulatory requirements and the approach to selecting and testing in nonclinical models. This is a unique and comprehensive reference that will inform and guide readers through the challenges and approaches to the safe and effective use of medications in children.”  (Doody’s, 17 August 2012)    

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