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" Pediatric nonclinical drug testing : "
edited by Alan M. Hoberman, Elise M. Lewis
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BL
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| Record Number
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629331
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| Doc. No
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dltt
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| Title & Author
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Pediatric nonclinical drug testing : : principles, requirements, and practices /\ edited by Alan M. Hoberman, Elise M. Lewis
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| Page. NO
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xv, 339 pages :: illustrations ;; 25 cm
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| ISBN
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9780470448618 (cloth)
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: 047044861X (cloth)
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| Bibliographies/Indexes
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Includes bibliographical references and index
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| Contents
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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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| Abstract
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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"--Provided by publisher
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| Subject
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Pediatric pharmacology-- Research-- United States
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Drugs-- Toxicology-- United States
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Drug Evaluation, Preclinical-- United States
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Age Factors-- United States
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Child-- United States
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Drug Approval-- United States
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Drug Toxicity-- prevention control-- United States
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Infant-- United States
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Models, Animal-- United States
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| Dewey Classification
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615.7/040287
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| LC Classification
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RJ560.P43 2012
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| NLM classification
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QV 771
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2012 E-065
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| Added Entry
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Hoberman, Alan M
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Lewis, Elise M
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| Parallel Title
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Pediatric non-clinical drug testing
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