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

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Pediatric Non-Clinical Drug Testing: Principles, Requirements, and Practice - Hoberman, Alan M. (Editor), and Lewis, Elise M. (Editor)
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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, ...

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Pediatric Non-Clinical Drug Testing: Principles, Requirements, and Practice 2012, John Wiley & Sons Inc, New York

ISBN-13: 9780470448618

Hardcover