Alan M. Hoberman,
Elise M. Lewis
John Wiley & Sons
e druk, 2012
9780470448618
Pediatric Non–Clinical Drug Testing
Principles, Requirements, and Practice
Specificaties
Gebonden, 356 blz.
|
Engels
John Wiley & Sons |
e druk, 2012
ISBN13: 9780470448618
Rubricering
Verwachte levertijd ongeveer 9 werkdagen
Samenvatting
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.
Specificaties
Inhoudsopgave
Preface ix
<p>Acknowledgments xi</p>
<p>Contributors xiii</p>
<p>1. Introduction 1<br /> Elise M. Lewis, Luc M. De Schaepdrijver, and Timothy P. Coogan</p>
<p>2. Overview of Pediatric Diseases and Clinical Considerations on Developing Medicines for Children 29<br /> Bert Suys and Jose Ramet</p>
<p>3. Nonclinical Safety Assessment for Biopharmaceuticals: Challenges and Strategies for Juvenile Animal Testing 41<br /> Timothy P. Coogan</p>
<p>4. FDA Approach to Pediatric Testing 59<br /> Robert E. Osterberg</p>
<p>5. Pediatric Drug Development Plans 79<br /> Kimberly C. Brannen and Beatriz Silva Lima</p>
<p>6. Application of Principles of Nonclinical Pediatric Drug Testing to the Hazard Evaluation of Environmental Contaminants 93<br /> Susan L. Makris</p>
<p>7. Nonclinical Testing Procedures Pharmacokinetics 115<br /> Loeckie L. de Zwart, Johan G. Monbaliu, and Pieter P. Annaert</p>
<p>8. Preclinical Development of a Pharmaceutical Product for Children 129<br /> Graham P. Bailey, Timothy P. Coogan, and Luc M. De Schaepdrijver</p>
<p>9. Juvenile Toxicity Study Design for the Rodent and Rabbit 141<br /> Alan M. Hoberman and John F. Barnett</p>
<p>10. Dog Juvenile Toxicity 183<br /> Keith Robinson, Susan Y. Smith, and Andre Viau</p>
<p>11. Use of the Swine Pediatric Model 213<br /> Paul C. Barrow</p>
<p>12. Juvenile Immunodevelopment in Minipigs 231<br /> Andr´e H. Penninks, Geertje J.D. van Mierlo, Frieke Kuper, Cor J. Snel, Niels–Christian Ganderup, and Andr´e P.M. Wolterbeek</p>
<p>13. Use of Primate Pediatric Model 255<br /> Gerhard F. Weinbauer, Gary J. Chellman, Allan Dahl Rasmussen and Elvira Vogelwedde</p>
<p>14. Approaches to Rat Juvenile Toxicity Studies and Case Studies: a Pharmaceutical Perspective 281<br /> Susan B. Laffan and Lorraine Posobiec</p>
<p>Appendix 1 Maturation of Organ Systems in Various Species 301</p>
<p>Appendix 2 Sample Juvenile Toxicity Testing Protocol 303</p>
<p>Index 331</p>
<p>Acknowledgments xi</p>
<p>Contributors xiii</p>
<p>1. Introduction 1<br /> Elise M. Lewis, Luc M. De Schaepdrijver, and Timothy P. Coogan</p>
<p>2. Overview of Pediatric Diseases and Clinical Considerations on Developing Medicines for Children 29<br /> Bert Suys and Jose Ramet</p>
<p>3. Nonclinical Safety Assessment for Biopharmaceuticals: Challenges and Strategies for Juvenile Animal Testing 41<br /> Timothy P. Coogan</p>
<p>4. FDA Approach to Pediatric Testing 59<br /> Robert E. Osterberg</p>
<p>5. Pediatric Drug Development Plans 79<br /> Kimberly C. Brannen and Beatriz Silva Lima</p>
<p>6. Application of Principles of Nonclinical Pediatric Drug Testing to the Hazard Evaluation of Environmental Contaminants 93<br /> Susan L. Makris</p>
<p>7. Nonclinical Testing Procedures Pharmacokinetics 115<br /> Loeckie L. de Zwart, Johan G. Monbaliu, and Pieter P. Annaert</p>
<p>8. Preclinical Development of a Pharmaceutical Product for Children 129<br /> Graham P. Bailey, Timothy P. Coogan, and Luc M. De Schaepdrijver</p>
<p>9. Juvenile Toxicity Study Design for the Rodent and Rabbit 141<br /> Alan M. Hoberman and John F. Barnett</p>
<p>10. Dog Juvenile Toxicity 183<br /> Keith Robinson, Susan Y. Smith, and Andre Viau</p>
<p>11. Use of the Swine Pediatric Model 213<br /> Paul C. Barrow</p>
<p>12. Juvenile Immunodevelopment in Minipigs 231<br /> Andr´e H. Penninks, Geertje J.D. van Mierlo, Frieke Kuper, Cor J. Snel, Niels–Christian Ganderup, and Andr´e P.M. Wolterbeek</p>
<p>13. Use of Primate Pediatric Model 255<br /> Gerhard F. Weinbauer, Gary J. Chellman, Allan Dahl Rasmussen and Elvira Vogelwedde</p>
<p>14. Approaches to Rat Juvenile Toxicity Studies and Case Studies: a Pharmaceutical Perspective 281<br /> Susan B. Laffan and Lorraine Posobiec</p>
<p>Appendix 1 Maturation of Organ Systems in Various Species 301</p>
<p>Appendix 2 Sample Juvenile Toxicity Testing Protocol 303</p>
<p>Index 331</p>