Pediatric Non-Clinical Drug Testing: Principles, Requirements, and Practice
Alan M. Hoberman
€ 138.15
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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.
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 ... Read more