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Pediatric Drug Development

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704 pages
Pediatric Drug Development: Concepts and Applications is designed as a reference and textbook and is meant to address the science of differences between the pediatric and adult subject in the development of pharmaceutical products. Considered are the ethics and medical needs of proper understanding the pediatric and adult differences, the business case for proper development of drugs for children, as well as the technical feasibility studies and processes that are necessary for a proper pediatric drug development program. The applications of these approaches will benefit all stakeholders and ultimately not only educate but also provide better and safer drugs for pediatric patients.
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PREFACE xiii
CONTRIBUTORS xv
PART I PAST, PRESENT, AND FUTURE OF PEDIATRIC DRUG DEVELOPMENT
1 A New Model for Children 3
Andrew E. Mulberg, John N. van den Anker, and Steven A. Silber
2 History of Pediatric Drug Development and Therapeutics 7
Stephen P. Spielberg
3 Perspectives on Pediatric Clinical Trials: The Good, the Bad, and the Ugly 11
Greg Koski
4 Population Dynamics, Demographics, and Disease Burden of Infants and Children Across the World 21

Christopher-Paul Milne
5 Pharmaceutical Economics and Applications to Pediatrics: Business Case Development 39
Christopher-Paul Milne
6 Pediatric Market Dynamics 59
Anne F. Clothier
7 Industry Benchmarks in Pediatric Clinical Trials 65
Cindy Levy-Petelinkar and Carolyn A. Campen
8 Novel Organizational Strategies for Advancing Pediatric Products: Business Case Development 69
Donald P. Lombardi
PART II ETHICAL UNDERPINNINGS
9 Additional Protections for Children Enrolled in Clinical Investigations 81
Robert M. Nelson
10 Ethical Issues in Neonatal Drug Development 103
Gerri R. Baer
11 Ethical Principles of Pediatric Research and Drug Development: A Guide Through National and International Frameworks and Applications to a Worldwide Perspective 115
Klaus Rose
PART III REGULATORY GUIDELINES FOR PEDIATRIC DRUG DEVELOPMENT: STIMULATION OF PEDIATRIC DRUG RESEARCH BY REGULATORY AUTHORITIES
12 United States Perspective 133
Samuel Maldonado
13 European Perspective 137
Klaus Rose
14 Japanese Perspective 153
Hidefumi Nakamura and Shunsuke Ono
15 Regulatory Considerations for Study of Generic Drugs Under Best Pharmaceuticals for Children Act: NICHD and FDA Collaboration 165
Sandra Cottrell and Brahm Goldstein
PART IV PRECLINICAL SAFETY ASSESSMENT
16 Introduction and Overview 175
Timothy P. Coogan
17 Preclinical Juvenile Toxicity Assessments and Study Designs 181
Luc M. De Schaepdrijver and Graham P. Bailey
18 Absorption, Distribution, Metabolism, and Excretion (ADME) and Pharmacokinetic Assessments in Juvenile Animals 201
Loeckie L. de Zwart, Johan G. Monbaliu, and Pieter P. Annaert
PART V PHARMACOLOGICAL PRINCIPLES IN PEDIATRIC DRUG DEVELOPMENT
19 Pediatric Clinical Pharmacology: Why, Where, How, When? 225
John N. van den Anker
20 Developmental Pharmacology Issues: Neonates, Infants, and Children 231
Natella Y. Rakhmanina and John N. van den Anker
21 Developmental Hepatic Pharmacology in Pediatrics 243
Martin Otto Behm
22 Applications of Pharmacogenomics to Study Design in Pediatrics 259
Nadine Cohen and Seth Ness
23 General Principles of Population Pharmacokinetics in Pediatrics 277
Mahesh Samtani and Hui Kimko
24 Development of Oncology Drugs for Children 285

Robin Norris, Wayne Rackoff, Steven Hirschfeld, and Peter C. Adamson
PART VI CLINICAL TRIAL OPERATIONS: UNDERSTANDING DIFFERENCES BETWEEN PEDIATRIC AND ADULT STUDY SUBJECTS—DEVELOPMENT ISSUES RELATED TO ORGAN DEVELOPMENT AND ENDPOINT CHOICES
25 Brain and Central Nervous System Development: Physiological Considerations for Assessment of Long-Term Safety 301
Eugene Schneider
26 Cognitive Development Considerations for Long-Term Safety Exposures in Children 313
Mary Pipan
27 Cardiovascular and QTc Issues 337
Bert Suys and Luc Dekie
28 Renal Function Issues 351
Katia Boven
29 Growth and Physical Maturation 363
Alisha J. Rovner and Babette S. Zemel
PART VII CLINICAL TRIAL OPERATIONS AND GOOD CLINICAL TRIALS
30 The Consent Process in Pediatric Clinical Trials 387
M. Renee Simar
31 Recruitment and Retention in Pediatric Clinical Trials 405
M. Renee Simar
32 Certification of Pediatric Clinical Investigators 417
A. Procaccino
33 Considerations and Barriers for Pediatric Patient Recruitment Strategy for Clinical Trials 419
Jennifer Niesz and Andrew E. Mulberg
34 Conducting Clinical Trials in Developing Countries: A Case Study 431
Leonard R. Friedland and Jacqueline M. Miller
35 The Importance of Geographic Differences in Pediatric Clinical Trials 437
Alexandar Cvetkovich Munta~nola
36 Partnering with Industry: Academic Medical Centers and Clinical Research Centers 451

Kate Owen, Matthew Hill, Sandra Cottrell, and Brahm Goldstein
PART VIII CLINICAL EFFICACY AND SAFETY ENDPOINTS
37 Laboratory Monitoring of Efficacy and Safety Parameters in Clinical Trials for Pediatric Subjects 467
Andrew E. Mulberg and Samuel Maldonado
38 Breath Testing in Pediatrics 481
Gigi Veereman-Wauters
39 Surrogate Endpoints: Application in Pediatric Clinical Trials 501
Geert Molenberghs and Camille Orman
40 Patient-Reported Outcomes in Pediatric Drug Development 513