Pediatric Non-Clinical Drug Testing: Principles, Requirements, and Practice (Google eBook)

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Alan M. Hoberman, Elise M. Lewis
John Wiley & Sons, Dec 28, 2011 - Medical - 320 pages
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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.
  

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Contents

Overview of Pediatric Diseases and Clinical
References
References
Agency EMA Approach to Pediatric Testing
4
Application of Principles of Nonclinical Pediatric
34
Nonclinical Testing ProceduresPharmacokinetics
4
Preclinical Development of a Pharmaceutical
15
References
24
References
9-29
References
10-25
Use of the Swine Pediatric Model
10-31
Juvenile Immunodevelopment in Minipigs
10-47
Use of Primate Pediatric Model
6
Approaches to Rat Juvenile Toxicity Studies
14
References
30
Index
85

Minipig
9-11

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About the author (2011)

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.

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