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Pediatric non-clinical drug testing principles, requirements, and practice
Title
Pediatric non-clinical drug testing [electronic resource] : principles, requirements, and practice / edited by Alan M. Hoberman, Elise M. Lewis.
ISBN
9780470448618 (cloth)
9781118168264 (e-book)
Published
Hoboken, N.J. : John Wiley & Sons, 2012.
Physical Description
xv, 339 p. : ill.
Local Notes
Access is available to the Yale community.
Notes
Electronic reproduction. Palo Alto, Calif. : ebrary, 2011. Available via World Wide Web. Access may be limited to ebrary affiliated libraries.
Access and use
Access restricted by licensing agreement.
Summary
"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"--Provided by publisher.
Format
Books / Online
Language
English
Added to Catalog
April 17, 2013
Bibliography
Includes bibliographical references.
Contents
Machine generated contents note: Introduction and the history of pediatric nonclinical drug testing / Elise M. Lewis, Luc M. deSchepdrijver, Timothy P. Coogan
Overview of pediatric diseases and clinical considerations on developing medicines for children / Bert Suys, Jose Ramet
Nonclinical safety assessment for biopharmaceuticals : challenges and strategies for juvenile animal testing / Timothy P. Coogan
FDA approach to pediatric testing / Robert E. Osterberg
Pediatric drug development plans / Kimberly Brennan, Beatriz Silva Lima
Application of principles of nonclinical pediatric drug testing to the hazard evaluation of environmental contaminants / Susan L. Makris
Nonclinical testing procedures - pharmacokinetics / Loeckie L. de Zwart, Johan G. Monbaliu, and Pieter P. Annaert
Preclinical development of a pharmaceutical product for children / Graham P. Bailey, Timothy P. Coogan, Luc M. De Schaepdrijver
Juvenile toxicity study design for the rodent and rabbit / Alan M. Hoberman, and John Barnett Jr.
Dog juvenile toxicity / Keith Robinson, Susan Y. Smith, and Andre Viau
Use of the swine pediatric model / Paul C. Barrow
Juvenile immuno-development in minipigs / Andre H Penninks ... [et al.]
Use of primate pediatric model / Gerhard F. Weinbauer
Approaches to rat juvenile toxicity studies and case studies : a pharmaceutical perspective / Susan B. Laffan, and Lorraine Posobiec.
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