Pediatric Non-Clinical Drug Testing: Principles, Requirements, and Practice [NOOK Book]

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Overview

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 ...
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Pediatric Non-Clinical Drug Testing: Principles, Requirements, and Practice

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Overview

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.
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Editorial Reviews

From the Publisher

“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.” (British Toxicology Society New, 1 November 2012)

“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.” (PJ Online, 11 September 2012)

“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.” (Doody’s, 17 August 2012)

From The Critics
Reviewer: Rachel R Chennault, PhD(American College of Clinical Pharmacy)
Description: Pediatric drug testing and off-label prescribing remain highly controversial topics, since generating data to support drug therapy in this vulnerable population remains challenging. This book examines the various practical, ethical, and regulatory issues surrounding the testing and labeling of medicinal drug products and devices for the safe and appropriate use in children. It also provides a historical perspective of the events that shaped the development of guidelines for nonclinical and clinical pediatric drug testing.
Purpose: The authors provide a guide through the rationale and methods for developing research designs to evaluate drug safety in children, including the use of appropriate animal models. This book addresses the necessary historical, physiological, and regulatory considerations for developing practical nonclinical drug testing programs.
Audience: It is intended for professionals in industrial, academic, clinical, and regulatory settings. As such, individuals who participate in the research, development, regulation, and prescribing of pharmaceutical products intended for use in children will benefit from the information this book provides from highly qualified international experts.
Features: An overview of the complexities inherent in the development, selection, and dosing of medications to treat children begins the book, with a particular focus on disease states that are either common or exclusive to pediatric patients. The authors expertly review the history of drug regulation in the U.S. and Europe, and describe governmental oversight to inform nonclinical, animal testing designed to determine the efficacy, safety, pharmacokinetics, and pharmacodynamics of drugs with potential pediatric indications. The remainder of the book is devoted to the selection of juvenile animal models, with a discussion of the appropriateness and challenges of each animal model based on how closely it mimics juvenile human development, physiology, metabolism, and intended routes of administration.
Assessment: 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.
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Product Details

  • ISBN-13: 9781118168257
  • Publisher: Wiley, John & Sons, Incorporated
  • Publication date: 12/28/2011
  • Sold by: Barnes & Noble
  • Format: eBook
  • Edition number: 1
  • Pages: 320
  • File size: 20 MB
  • Note: This product may take a few minutes to download.

Meet the Author

ALAN M. HOBERMAN, PhD, DABT, Fellow ATS, is Executive Director of Site Operations and Toxicology at Charles River Preclinical Services, Horsham, PA.

ELISE M. LEWIS, PhD, is Director of Reproductive and Neurobehavioral Toxicology at Charles River Preclinical Services, Horsham, PA.

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Table of Contents

Preface ix

Acknowledgments xi

Contributors xiii

1. Introduction 1
Elise M. Lewis, Luc M. De Schaepdrijver, and Timothy P. Coogan

2. Overview of Pediatric Diseases and Clinical Considerations on Developing Medicines for Children 29
Bert Suys and Jose Ramet

3. Nonclinical Safety Assessment for Biopharmaceuticals: Challenges and Strategies for Juvenile Animal Testing 41
Timothy P. Coogan

4. FDA Approach to Pediatric Testing 59
Robert E. Osterberg

5. Pediatric Drug Development Plans 79
Kimberly C. Brannen and Beatriz Silva Lima

6. Application of Principles of Nonclinical Pediatric Drug Testing to the Hazard Evaluation of Environmental Contaminants 93
Susan L. Makris

7. Nonclinical Testing Procedures—Pharmacokinetics 115
Loeckie L. de Zwart, Johan G. Monbaliu, and Pieter P. Annaert

8. Preclinical Development of a Pharmaceutical Product for Children 129
Graham P. Bailey, Timothy P. Coogan, and Luc M. De Schaepdrijver

9. Juvenile Toxicity Study Design for the Rodent and Rabbit 141
Alan M. Hoberman and John F. Barnett

10. Dog Juvenile Toxicity 183
Keith Robinson, Susan Y. Smith, and Andre Viau

11. Use of the Swine Pediatric Model 213
Paul C. Barrow

12. Juvenile Immunodevelopment in Minipigs 231
Andr´e H. Penninks, Geertje J.D. van Mierlo, Frieke Kuper, Cor J. Snel, Niels-Christian Ganderup, and Andr´e P.M. Wolterbeek

13. Use of Primate Pediatric Model 255
Gerhard F. Weinbauer, Gary J. Chellman, Allan Dahl Rasmussen and Elvira Vogelwedde

14. Approaches to Rat Juvenile Toxicity Studies and Case Studies: a Pharmaceutical Perspective 281
Susan B. Laffan and Lorraine Posobiec

Appendix 1 Maturation of Organ Systems in Various Species 301

Appendix 2 Sample Juvenile Toxicity Testing Protocol 303

Index 331

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