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Pediatric Drug Development
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Pediatric Drug Development
624eBook
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Overview
Product Details
ISBN-13: | 9781118312056 |
---|---|
Publisher: | Wiley |
Publication date: | 05/20/2013 |
Sold by: | JOHN WILEY & SONS |
Format: | eBook |
Pages: | 624 |
File size: | 7 MB |
About the Author
Table of Contents
List of ContributorsPreface
Part I: PAST, PRESENT, AND FUTURE OF PEDIATRIC DRUG DEVELOPMENT 1 Pediatric Drug Development and Therapeutics: Continued Progress for Better Drugs for Children Andrew E. Mulberg, Lisa Mathis, Julia Dunne and Dianne Murphy
2 History of Children and the Development of Regulations at the FDA Robert M. Ward and Steven Hirschfeld
3 Population Dynamics, Demographics, and Disease Burden of Infants and Children Across the World Ashley Malins and Christopher-Paul Milne
4 Pharmaceutical Economics and Market Access for Pediatric Medications Christopher-Paul Milne and Ashley Malins
5 The Global Pediatric Market and Drivers of Pediatric Drug Development E. Michael D. Scott
6 Industry Benchmarks in Pediatric Clinical Trials Carolyn A. Campen and Cindy Levy-Petelinkar
Part II: ETHICAL UNDERPINNINGS 7 Ethical and practical considerations in conducting neonatal research Michelle Roth-Cline and Robert M. Nelson
8 Ethical considerations in conducting pediatric research Michelle Roth-Cline and Robert M. Nelson
9 The Consent and Assent Process in Pediatric Clinical Trials M. Renee Simar
Part III: REGULATORY GUIDELINES FOR PEDIATRIC DRUG DEVELOPMENT 10 A Sponsor’s Perspective of US Regulations Samuel Maldonado
11 FDA experience of extrapolation of efficacy to the pediatric population from adult and other data Julia Dunne, William J. Rodriguez and Dianne Murphy
12 Accelerated Approval and other regulatory approaches to the development of drugs for serious or life-threatening diseases in pediatrics Therese Cvetkovich
13 Rare Diseases and Orphan Drugs Anne R. Pariser and Lynne P. Yao
14 European Perspective Agnès Saint-Raymond
15 Five years of pediatric legislation in the European Union Agnès Saint-Raymond and Ralf Herold
16 Japanese Perspective Hidefumi Nakamura and Shunsuke Ono
17 Pediatric Device Development in the United States Priya Venkataraman-Rao and Joy Samuels-Reid
Part IV: PRECLINICAL SAFETY ASSESSMENT 18 Introduction and Overview Timothy P. Coogan and Melissa S. Tassinari
19 Juvenile Animal Toxicity Assessments: Decision Strategies and Study Design Luc M. De Schaepdrijver, Graham P. Bailey, Timothy P. Coogan and Jennifer L. Ingram-Ross
20 Absorption, Distribution, Metabolism and Excretion (ADME) and Pharmacokinetic Assessments in Juvenile Animals Loeckie L. de Zwart, Johan G. Monbaliu and Pieter P. Annaert
21 A Global Regulatory Perspective Karen Davis-Bruno, Jacqueline Carleer, Beatriz Silva Lima and Melissa S. Tassinari
22 Disease specific models to enhance Pediatric drug development Niraj R. Mehta and Sruthi King
Part V: PHARMACOLOGICAL PRINCIPLES IN PEDIATRIC DRUG DEVELOPMENT 23 Pediatric Clinical Pharmacology in Regulatory and Drug Development Sciences: Lessons learned and the Path Forward Gilbert J. Burckart and Jeremiah Momper
24 Development and Clinical Trial Design Kathleen A. Neville, Ralph E. Kauffman, and Susan M. Abdel-Rahman
25 Developmental Hepatic Pharmacology in Pediatrics Martin Otto Behm
26 Applications of Population Pharmacokinetics for Pediatric Drug Development Jeremiah Momper, Gilbert J. Burckart and Pravin Jadhav
27 Applications of Pharmacogenomics to Pediatric Drug Development Gilbert J. Burckart, Dionna Green and Padmaja Mummaneni
28 Pharmacometrics Applications to Pediatric Trials Devin Pastoor, Mallika Lala, Jogarao V.S. Gobburu
Part VI: CLINICAL TRIAL OPERATIONS 29 Brain and Central Nervous System Development: Physiological Considerations for Assessment of Long-Term Safety Kachikwu Illoh
30 Cognitive Development Considerations for Long-Term Safety Exposures in Children Mary Pipan, Paul Wang, and Rebecca Thompson-Penna
31 Cardiovascular and QTc Issues Bert Suys and Luc Dekie
32 Pediatric bone and adult bone – physiological differences Francisco A. Sylvester and Erica L. Wynn
33 Renal Function Issues Katia Boven
34 Growth and Physical Development Alisha J. Rovner and Babette S. Zemel
35 Development of Drugs for Pediatric Cancers Kristen M. Snyder, Martha Donoghue, Whitney S. Helms, and Gregory Reaman
Part VII: CLINICAL TRIAL OPERATIONS AND GOOD CLINICAL TRIALS 36 Recruitment and Retention in Pediatric Clinical Trials: Focus on Networks in the US and EU Rosalind L. Smyth, Geetinder Kaur, Daniel Benjamin Jr, and Matthew Laughon
37 Recruitment and Retention of Minority populations in Clinical Trials Benjamin Ortiz and Sergio Guerrero
38 Conducting Clinical Trials in Developing and Emerging Countries: Review and Case Study Kevin D. Hill and Jennifer S. Li
39 The Importance of Geographic Differences in Pediatric Clinical Trials Alexandar Cvetkovich Muntañola
Part VIII: CLINICAL EFFICACY AND SAFETY ENDPOINTS 40 Clinical Laboratory Testing in Clinical Trials for Pediatric Subjects Andrew E. Mulberg and Ethan D. Hausman 41 Surrogate Endpoints: Application in Pediatric Clinical Trials Geert Molenberghs
42 Clinical Outcome Assessments for Clinical Trials in Children Elektra J. Papadopoulos, Donald L. Patrick, Melissa S. Tassinari, Andrew E. Mulberg, Carla Epps, Anne R. Pariser and Laurie B. Burke
43 Challenges in Evaluating the Safety of Pediatric Therapeutic Agents in Trials and Post-Marketing Studies Ann W. McMahon, Chris Feudtner and Dianne Murphy
44 Endpoints in Rare Diseases Anne R. Pariser and Lynne P. Yao
Part IX: FORMULATION, CHEMISTRY, AND MANUFACTURING CONTROLS 45 Formulation, Chemistry, and Manufacturing Controls Gerard P. McNally and Aniruddha M. Railkar
46 Drug Delivery Challenges for the Pediatric Patient: Novel Forms for Consideration Ann Zajicek 47 The Jelly Bean Test: A Novel Technique To Help Children Swallow Medications Robbyn E. Sockolow and Aliza B. Solomon
Index