Pediatric Drug Development: Concepts and Applications

Pediatric Drug Development: Concepts and Applications

Editor(s): Andrew E. Mulberg, Dianne Murphy, Julia Dunne, Lisa L. Mathis

Published Online: 31 JUL 2013

Print ISBN: 9781118312155

Online ISBN: 9781118312087

DOI: 10.1002/9781118312087

About this Book

Most medicines have never been adequately tested for safety and efficacy in pediatric populations and preterm, infants and children are particularly vulnerable to adverse drug reactions.

Pediatric Drug Development: Concepts and Applications
, Second Edition, addresses the unique challenges in conducting effective drug research and development in pediatric populations.

This new edition covers the legal and ethical issues of consent and assent, the additional legal and safety protections for children, and the appropriate methods of surveillance and assessment for children of varying ages and maturity, particularly for patient reported outcomes. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of global pediatric drug development. It also encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children globally.

From an international team of expert contributors Pediatric Drug Development: Concepts and Applications is the practical guide to all aspects of the research and development of safe and effective medicines for children.

Table of contents

    1. You have free access to this content
    2. Chapter 19

      Juvenile Animal Toxicity Assessments: Decision Strategies and Study Design (pages 201–221)

      Luc M. De Schaepdrijver, Graham P. Bailey, Timothy P. Coogan and Jennifer L. Ingram-Ross

    3. Chapter 21

      A Global Regulatory Perspective (pages 246–256)

      Karen L. Davis-Bruno, Jacqueline Carleer, Beatriz Silva Lima and Melissa S. Tassinari

    4. Chapter 24

      Development and Clinical Trial Design (pages 281–291)

      Kathleen A. Neville, Ralph E. Kauffman and Susan M. Abdel-Rahman

    5. Chapter 35

      Development of Drugs for Pediatric Cancers (pages 438–452)

      Kristen M. Snyder, Martha Donoghue, Whitney S. Helms and Gregory Reaman

    6. Chapter 42

      Clinical Outcome Assessments for Clinical Trials in Children (pages 539–548)

      Elektra J. Papadopoulos, Donald L. Patrick, Melissa S. Tassinari, Andrew E. Mulberg, Carla Epps, Anne R. Pariser and Laurie B. Burke

    7. You have free access to this content