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Informationen zum Autor Andrew E. Mulberg, Division Deputy Director, Gastroenterology and Inborn Error Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, US Dianne Murphy, Director, Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, US Julia Dunne, Vigilance and Risk Management in Medicines (VRMM), Medicines and Healthcare Products Regulatory Agency, London, UK Lisa L. Mathis, Executive Director for Global Regulatory Affairs and Safety (GRAAS), Amgen Incorporated, Thousand Oaks, California, US Klappentext 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. Zusammenfassung Pediatric Drug Development! Second Edition! encompasses the new regulatory initiatives across EU! US and ROW designed to encourage improved access to safe and effective medicines for children. It includes new developments in biomarkers and surrogate endpoints! developmental pharmacology and other novel aspects of pediatric drug development. Inhaltsverzeichnis List of Contributors Preface 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 <...
