{"product_id":"pediatric-non-clinical-drug-testing-principles-requirements-and-practice-hardback-9780470448618","title":"Pediatric Non-Clinical Drug Testing; Principles, Requirements, and Practice (Hardback) 9780470448618","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003ePediatric Non-Clinical Drug Testing\u003c\/font\u003e\u003cbr\u003e\r\n\u003cfont size=\"5\"\u003ePrinciples, Requirements, and Practice\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\u003cp\u003e\u003cfont size=\"4\"\u003eAlan M. Hoberman (Edited by), AM Hoberman (Author), Elise M. Lewis (Edited by)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9780470448618, Wiley\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eHardback, published 27 March 2012\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e384 pages\u003cbr\u003e24.1 x 16.3 x 2.8 cm, 0.717 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cem\u003e\u003cfont size=\"3\"\u003e\u003cp\u003e“Overall, this is a very useful book in bringing together many of the aspects associated with JA toxicology testing of pharmaceuticals for the first time, especially for those new to this growing field, with the chapters on study design considerations being especially useful.”  (\u003ci\u003eBritish Toxicology Society New\u003c\/i\u003e, 1 November 2012)\u003c\/p\u003e \u003cp\u003e“The book is an essential reference for international regulatory personnel, toxicologists, pharmacokineticists, scientists working in the pharmaceutical industry, academics and physicians and pharmacists concerned about the safe use of medicines in children\u003cb\u003e.\u003c\/b\u003e”  (\u003ci\u003ePharmaceutical Journal\u003c\/i\u003e, 11 September 2012)\u003c\/p\u003e \u003cp\u003e“No other single resource combines pediatric drug development considerations with the most recent regulatory requirements and the approach to selecting and testing in nonclinical models. This is a unique and comprehensive reference that will inform and guide readers through the challenges and approaches to the safe and effective use of medications in children.”  (\u003ci\u003eDoody’s\u003c\/i\u003e, 17 August 2012)\u003c\/p\u003e \u003cp\u003e \u003c\/p\u003e \u003cp\u003e \u003c\/p\u003e\u003c\/font\u003e\u003c\/em\u003e\u003c\/p\u003e\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003eThis 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.\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e\u003cp\u003ePreface ix\u003c\/p\u003e \u003cp\u003eAcknowledgments xi\u003c\/p\u003e \u003cp\u003eContributors xiii\u003c\/p\u003e \u003cp\u003e1. Introduction 1\u003cbr\u003e \u003ci\u003eElise M. Lewis, Luc M. De Schaepdrijver, and Timothy P. Coogan\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2. Overview of Pediatric Diseases and Clinical Considerations on Developing Medicines for Children 29\u003cbr\u003e \u003ci\u003eBert Suys and José Ramet\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3. Nonclinical Safety Assessment for Biopharmaceuticals: Challenges and Strategies for Juvenile Animal Testing 41\u003cbr\u003e \u003ci\u003eTimothy P. Coogan\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4. FDA Approach to Pediatric Testing 59\u003cbr\u003e \u003ci\u003eRobert E. Osterberg\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5. Pediatric Drug Development Plans 79\u003cbr\u003e \u003ci\u003eKimberly C. Brannen and Beatriz Silva Lima\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6. Application of Principles of Nonclinical Pediatric Drug Testing to the Hazard Evaluation of Environmental Contaminants 93\u003cbr\u003e \u003ci\u003eSusan L. Makris\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7. Nonclinical Testing Procedures—Pharmacokinetics 115\u003cbr\u003e \u003ci\u003eLoeckie L. de Zwart, Johan G. Monbaliu, and Pieter P. Annaert\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8. Preclinical Development of a Pharmaceutical Product for Children 129\u003cbr\u003e \u003ci\u003eGraham P. Bailey, Timothy P. Coogan, and Luc M. De Schaepdrijver\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9. Juvenile Toxicity Study Design for the Rodent and Rabbit 141\u003cbr\u003e \u003ci\u003eAlan M. Hoberman and John F. Barnett\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10. Dog Juvenile Toxicity 183\u003cbr\u003e \u003ci\u003eKeith Robinson, Susan Y. Smith, and Andre Viau\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11. Use of the Swine Pediatric Model 213\u003cbr\u003e \u003ci\u003ePaul C. Barrow\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12. Juvenile Immunodevelopment in Minipigs 231\u003cbr\u003e \u003ci\u003eAndré H. Penninks, Geertje J.D. van Mierlo, Frieke Kuper, Cor J. Snel, Niels-Christian Ganderup, and André P.M. Wolterbeek\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13. Use of Primate Pediatric Model 255\u003cbr\u003e \u003ci\u003eGerhard F. Weinbauer, Gary J. Chellman, Allan Dahl Rasmussen, and Elvira Vogelwedde\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e14. Approaches to Rat Juvenile Toxicity Studies and Case Studies: a Pharmaceutical Perspective 281\u003cbr\u003e \u003ci\u003eSusan B. Laffan and Lorraine Posobiec\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eAppendix 1 Maturation of Organ Systems in Various Species 301\u003c\/p\u003e \u003cp\u003eAppendix 2 Sample Juvenile Toxicity Testing Protocol 303\u003c\/p\u003e \u003cp\u003eIndex 331\u003c\/p\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Chemistry [\u003ca title=\"See our other books on Chemistry\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Chemistry%20%5BPN%5D%22\"\u003ePN\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Wiley","offers":[{"title":"Brand New","offer_id":52276280623384,"sku":"9780470448618","price":90.58,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0730\/2037\/5320\/files\/9780470448618.jpg?v=1781366119","url":"https:\/\/freshlyprintedbooks.co.uk\/products\/pediatric-non-clinical-drug-testing-principles-requirements-and-practice-hardback-9780470448618","provider":"Freshly Printed Books","version":"1.0","type":"link"}