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Pediatric Nonclinical Drug Testing: Principles, Requirements, and Practices

by Alan M. Hoberman
Save 12% Save 12%
Current price ₹11,808.00
Original price ₹13,403.00
Original price ₹13,403.00
Original price ₹13,403.00
(-12%)
₹11,808.00
Current price ₹11,808.00

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Book cover type: Hardcover
  • ISBN13: 9780470448618
  • Binding: Hardcover
  • Subject: N/A
  • Publisher: Wiley
  • Publisher Imprint: Wiley
  • Publication Date:
  • Pages: 339
  • Original Price: GBP 105.95
  • Language: English
  • Edition: N/A
  • Item Weight: 545 grams
  • BISAC Subject(s): Pharmacology and Pediatrics

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.

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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