Description |
1 online resource |
Contents |
Introduction / Elise M Lewis, Luc M De Schaepdrijver, 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 C Brannen, 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, 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, John F Barnett -- Dog Juvenile Toxicity / Keith Robinson, Susan Y Smith, Andre Viau -- Use of the Swine Pediatric Model / Paul C Barrow -- Juvenile Immunodevelopment in Minipigs / Andre H Penninks, Geertje J D van Mierlo, Frieke Kuper, Cor J Snel, Niels-Christian Ganderup, Andre P M Wolterbeek -- Use of Primate Pediatric Model / Gerhard F Weinbauer, Gary J Chellman, Allan Dahl Rasmussen, Elvira Vogelwedde -- Approaches to Rat Juvenile Toxicity Studies and Case Studies: a Pharmaceutical Perspective / Susan B Laffan, Lorraine Posobiec -- Appendix 1: Maturation of Organ Systems in Various Species -- Appendix 2: Sample Juvenile Toxicity Testing Protocol |
Notes |
Includes index |
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Mode of access: World Wide Web |
Subject |
Children -- Drug testing.
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Drugs -- Toxicology.
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Form |
Electronic book
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Author |
Hoberman, Alan M.
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Wiley InterScience (Online service)
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ISBN |
1118168224 (electronic bk.) |
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9781118168226 (electronic bk.) |
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