{"product_id":"pediatric-drug-development-isbn-9781118312155","title":"Pediatric Drug Development","description":"\u003cp\u003eMost 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.\u003cbr\u003e\u003ci\u003e\u003cbr\u003ePediatric Drug Development: Concepts and Applications\u003c\/i\u003e, Second Edition, addresses the unique challenges in conducting effective drug research and development in pediatric populations.\u003cbr\u003e\u003cbr\u003eThis 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.\u003cbr\u003e\u003cbr\u003eFrom an international team of expert contributors \u003ci\u003ePediatric Drug Development: Concepts and Applications\u003c\/i\u003e is the practical guide to all aspects of the research and development of safe and effective medicines for children.\u003c\/p\u003e  \u003cp\u003eList of Contributors\u003c\/p\u003e \u003cp\u003ePreface\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart I: PAST, PRESENT, AND FUTURE OF PEDIATRIC DRUG DEVELOPMENT\u003c\/b\u003e\u003cbr\u003e  \u003cbr\u003e 1 Pediatric Drug Development and Therapeutics: Continued Progress for Better Drugs for Children\u003cbr\u003e \u003ci\u003eAndrew E. Mulberg, Lisa Mathis, Julia Dunne and Dianne Murphy\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2 History of Children and the Development of Regulations at the FDA\u003cbr\u003e \u003ci\u003eRobert M. Ward and Steven Hirschfeld\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3 Population Dynamics, Demographics, and Disease Burden of Infants and Children Across the World\u003cbr\u003e \u003ci\u003eAshley Malins and Christopher-Paul Milne\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4 Pharmaceutical Economics and Market Access for Pediatric  Medications\u003cbr\u003e \u003ci\u003eChristopher-Paul Milne and Ashley Malins\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5 The Global Pediatric Market and Drivers of Pediatric Drug Development\u003cbr\u003e \u003ci\u003eE. Michael D. Scott\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6 Industry Benchmarks in Pediatric Clinical Trials\u003cbr\u003e \u003ci\u003eCarolyn A. Campen and Cindy Levy-Petelinkar\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart II: ETHICAL UNDERPINNINGS\u003c\/b\u003e\u003cbr\u003e  \u003cbr\u003e 7 Ethical and practical considerations in conducting neonatal research\u003cbr\u003e \u003ci\u003eMichelle Roth-Cline and Robert M. Nelson\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8 Ethical considerations in conducting pediatric research \u003cbr\u003e \u003ci\u003eMichelle Roth-Cline and Robert M. Nelson\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9 The Consent and Assent Process in Pediatric Clinical Trials\u003cbr\u003e \u003ci\u003eM. Renee Simar\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart III: REGULATORY GUIDELINES FOR PEDIATRIC DRUG DEVELOPMENT\u003c\/b\u003e\u003cbr\u003e  \u003cbr\u003e 10 A Sponsor’s Perspective of US Regulations\u003cbr\u003e \u003ci\u003eSamuel Maldonado\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11 FDA experience of extrapolation of efficacy to the pediatric population from adult and other data\u003cbr\u003e \u003ci\u003eJulia Dunne, William J. Rodriguez and Dianne Murphy\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12 Accelerated Approval and other regulatory approaches to the development of drugs for serious or life-threatening diseases in pediatrics\u003cbr\u003e \u003ci\u003eTherese Cvetkovich\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13 Rare Diseases and Orphan Drugs\u003cbr\u003e \u003ci\u003eAnne R. Pariser and Lynne P. Yao\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e14 European Perspective\u003cbr\u003e \u003ci\u003eAgnès Saint-Raymond\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15 Five years of pediatric legislation in the European Union\u003cbr\u003e \u003ci\u003eAgnès Saint-Raymond and Ralf Herold\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e16 Japanese Perspective\u003cbr\u003e \u003ci\u003eHidefumi Nakamura and Shunsuke Ono\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e17 Pediatric Device Development in the United States\u003cbr\u003e \u003ci\u003ePriya Venkataraman-Rao and Joy Samuels-Reid\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart IV: PRECLINICAL SAFETY ASSESSMENT\u003c\/b\u003e\u003cbr\u003e  \u003cbr\u003e 18 Introduction and Overview\u003cbr\u003e \u003ci\u003eTimothy P. Coogan and Melissa S. Tassinari\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e19 Juvenile Animal Toxicity Assessments: Decision Strategies and Study Design\u003cbr\u003e \u003ci\u003eLuc M. De Schaepdrijver,  Graham P. Bailey, Timothy P. Coogan and Jennifer L. Ingram-Ross\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e20 Absorption, Distribution, Metabolism and Excretion (ADME) and Pharmacokinetic Assessments in Juvenile Animals\u003cbr\u003e \u003ci\u003eLoeckie L. de Zwart, Johan G. Monbaliu and Pieter P. Annaert\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e21 A Global Regulatory Perspective\u003cbr\u003e \u003ci\u003eKaren Davis-Bruno, Jacqueline Carleer, Beatriz Silva Lima and Melissa S. Tassinari\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e22 Disease specific models to enhance Pediatric drug development\u003cbr\u003e \u003ci\u003eNiraj R. Mehta and Sruthi King\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart V: PHARMACOLOGICAL PRINCIPLES IN PEDIATRIC DRUG DEVELOPMENT\u003c\/b\u003e\u003cbr\u003e  \u003cbr\u003e 23 Pediatric Clinical Pharmacology in Regulatory and Drug Development Sciences:  Lessons learned and the Path Forward\u003cbr\u003e \u003ci\u003eGilbert J. Burckart and Jeremiah Momper\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e24 Development and Clinical Trial Design\u003cbr\u003e \u003ci\u003eKathleen A. Neville, Ralph E. Kauffman, and Susan M. Abdel-Rahman\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e25 Developmental Hepatic Pharmacology in Pediatrics\u003cbr\u003e \u003ci\u003eMartin Otto Behm\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e26 Applications of Population Pharmacokinetics for Pediatric Drug Development\u003cbr\u003e \u003ci\u003eJeremiah Momper, Gilbert J. Burckart and Pravin Jadhav\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e27 Applications of Pharmacogenomics to Pediatric Drug Development \u003cbr\u003e \u003ci\u003eGilbert J. Burckart, Dionna Green and Padmaja Mummaneni\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e28 Pharmacometrics Applications to Pediatric Trials\u003cbr\u003e \u003ci\u003eDevin Pastoor, Mallika Lala, Jogarao V.S. Gobburu\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart VI: CLINICAL TRIAL OPERATIONS\u003c\/b\u003e\u003cbr\u003e  \u003cbr\u003e 29 Brain and Central Nervous System Development: Physiological Considerations for Assessment of Long-Term Safety\u003cbr\u003e \u003ci\u003eKachikwu Illoh\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e30 Cognitive Development Considerations for Long-Term Safety Exposures in Children\u003cbr\u003e \u003ci\u003eMary Pipan, Paul Wang,  and Rebecca Thompson-Penna\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e31 Cardiovascular and QTc Issues\u003cbr\u003e \u003ci\u003eBert Suys and  Luc Dekie\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e32 Pediatric bone and adult bone – physiological differences\u003cbr\u003e \u003ci\u003eFrancisco A. Sylvester and Erica L. Wynn\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e33 Renal Function Issues\u003cbr\u003e \u003ci\u003eKatia Boven\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e34 Growth and Physical Development\u003cbr\u003e \u003ci\u003eAlisha J. Rovner and  Babette S. Zemel\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e35 Development of Drugs for Pediatric Cancers\u003cbr\u003e \u003ci\u003eKristen M. Snyder, Martha Donoghue, Whitney S. Helms, and Gregory Reaman\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart VII: CLINICAL TRIAL OPERATIONS AND GOOD CLINICAL TRIALS\u003c\/b\u003e\u003cbr\u003e  \u003cbr\u003e 36 Recruitment and Retention in Pediatric Clinical Trials: Focus on Networks  in the US and EU Rosalind \u003ci\u003eL. Smyth, Geetinder Kaur, Daniel Benjamin Jr, and Matthew Laughon\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e37 Recruitment and Retention of Minority populations in Clinical Trials\u003cbr\u003e \u003ci\u003eBenjamin Ortiz and Sergio Guerrero\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e38 Conducting Clinical Trials in Developing and Emerging Countries:  Review and Case Study\u003cbr\u003e \u003ci\u003eKevin D. Hill and Jennifer S. Li\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e39 The Importance of Geographic Differences in Pediatric Clinical Trials\u003cbr\u003e \u003ci\u003eAlexandar Cvetkovich Muntañola\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart VIII: CLINICAL EFFICACY AND SAFETY ENDPOINTS\u003c\/b\u003e\u003cbr\u003e  \u003cbr\u003e 40 Clinical Laboratory Testing in Clinical Trials for Pediatric Subjects\u003cbr\u003e \u003ci\u003eAndrew E. Mulberg and Ethan D. Hausman\u003c\/i\u003e\u003cbr\u003e  \u003cbr\u003e 41 Surrogate Endpoints: Application in Pediatric Clinical Trials\u003cbr\u003e \u003ci\u003eGeert Molenberghs\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e42 Clinical Outcome Assessments for Clinical Trials in Children\u003cbr\u003e \u003ci\u003eElektra J. Papadopoulos,  Donald L. Patrick,  Melissa S. Tassinari,  Andrew E. Mulberg,  Carla Epps, \u003c\/i\u003e \u003ci\u003eAnne R. Pariser and  Laurie B. Burke\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e43 Challenges in Evaluating the Safety of Pediatric Therapeutic Agents in Trials and Post-Marketing Studies\u003cbr\u003e \u003ci\u003eAnn W. McMahon, Chris Feudtner and Dianne Murphy\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e44 Endpoints in Rare Diseases\u003cbr\u003e \u003ci\u003eAnne R. Pariser and Lynne P. Yao\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart IX: FORMULATION, CHEMISTRY, AND MANUFACTURING CONTROLS\u003c\/b\u003e\u003cbr\u003e  \u003cbr\u003e 45 Formulation, Chemistry, and Manufacturing Controls\u003cbr\u003e \u003ci\u003eGerard P. McNally and Aniruddha M. Railkar\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e46 Drug Delivery Challenges for the Pediatric Patient: Novel Forms for  Consideration\u003cbr\u003e \u003ci\u003eAnn Zajicek\u003c\/i\u003e\u003cbr\u003e  \u003cbr\u003e 47 The Jelly Bean Test: A Novel Technique To Help Children Swallow Medications\u003cbr\u003e \u003ci\u003eRobbyn E. Sockolow and Aliza B. Solomon\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIndex\u003c\/p\u003e \u003cp\u003eAndrew 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\u003cbr\u003e\u003cbr\u003eDianne Murphy, Director, Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, US\u003cbr\u003e\u003cbr\u003eJulia Dunne, Vigilance and Risk Management in Medicines (VRMM), Medicines and Healthcare Products Regulatory Agency, London, UK\u003cbr\u003e\u003cbr\u003eLisa L. Mathis, Executive Director for Global Regulatory Affairs and Safety (GRAAS), Amgen Incorporated, Thousand Oaks, California, US\u003c\/p\u003e \u003cp\u003eMost 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.\u003cbr\u003e\u003ci\u003e\u003cbr\u003ePediatric Drug Development: Concepts and Applications\u003c\/i\u003e, Second Edition, addresses the unique challenges in conducting effective drug research and development in pediatric populations.\u003cbr\u003e\u003cbr\u003eThis 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.\u003cbr\u003e\u003cbr\u003eFrom an international team of expert contributors \u003ci\u003ePediatric Drug Development: Concepts and Applications\u003c\/i\u003e is the practical guide to all aspects of the research and development of safe and effective medicines for children.\u003c\/p\u003e","brand":"Wiley-Blackwell","offers":[{"title":"Default Title","offer_id":47989758460133,"sku":"NP9781118312155","price":179.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781118312155.jpg?v=1761785377","url":"https:\/\/k12savings.com\/es\/products\/pediatric-drug-development-isbn-9781118312155","provider":"K12savings","version":"1.0","type":"link"}