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Pediatric drug development : concepts and applications /

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...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Mulberg, Andrew E., Silber, Steven A., Van den Anker, John N.
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Hoboken, N.J. : John Wiley, ©2009.
Temas:
Acceso en línea:Texto completo

MARC

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082 0 4 |a 615/.190083  |2 22 
049 |a UAMI 
245 0 0 |a Pediatric drug development :  |b concepts and applications /  |c edited by Andrew E. Mulberg, Steven A. Silber, John N. van den Anker. 
260 |a Hoboken, N.J. :  |b John Wiley,  |c ©2009. 
300 |a 1 online resource (xx, 683 pages) :  |b illustrations 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
504 |a Includes bibliographical references and index. 
588 0 |a Print version record. 
505 0 |a PEDIATRIC DRUG DEVELOPMENT -- CONTENTS -- PREFACE -- CONTRIBUTORS -- PART I PAST, PRESENT, AND FUTURE OF PEDIATRIC DRUG DEVELOPMENT -- 1 A New Model for Children -- 2 History of Pediatric Drug Development and Therapeutics -- 3 Perspectives on Pediatric Clinical Trials: The Good, the Bad, and the Ugly -- 4 Population Dynamics, Demographics, and Disease Burden of Infants and Children Across the World -- 5 Pharmaceutical Economics and Applications to Pediatrics: Business Case Development -- 6 Pediatric Market Dynamics 
505 8 |a 7 Industry Benchmarks in Pediatric Clinical Trials8 Novel Organizational Strategies for Advancing Pediatric Products: Business Case Development -- PART II ETHICAL UNDERPINNINGS -- 9 Additional Protections for Children Enrolled in Clinical Investigations -- 10 Ethical Issues in Neonatal Drug Development -- 11 Ethical Principles of Pediatric Research and Drug Development: A Guide Through National and International Frameworks and Applications to a Worldwide Perspective 
505 8 |a PART III REGULATORY GUIDELINES FOR PEDIATRIC DRUG DEVELOPMENT: STIMULATION OF PEDIATRIC DRUG RESEARCH BY REGULATORY AUTHORITIES12 United States Perspective -- 13 European Perspective -- 14 Japanese Perspective -- 15 Regulatory Considerations for Study of Generic Drugs Under Best Pharmaceuticals for Children Act: NICHD and FDA Collaboration -- PART IV PRECLINICAL SAFETY ASSESSMENT -- 16 Introduction and Overview -- 17 Preclinical Juvenile Toxicity Assessments and Study Designs 
505 8 |a 18 Absorption, Distribution, Metabolism, and Excretion (ADME) and Pharmacokinetic Assessments in Juvenile AnimalsPART V PHARMACOLOGICAL PRINCIPLES IN PEDIATRIC DRUG DEVELOPMENT -- 19 Pediatric Clinical Pharmacology: Why, Where, How, When? -- 20 Developmental Pharmacology Issues: Neonates, Infants, and Children -- 21 Developmental Hepatic Pharmacology in Pediatrics -- 22 Applications of Pharmacogenomics to Study Design in Pediatrics -- 23 General Principles of Population Pharmacokinetics in Pediatrics -- 24 Development of Oncology Drugs for Children 
505 8 |a PART VI CLINICAL TRIAL OPERATIONS: UNDERSTANDING DIFFERENCES BETWEEN PEDIATRIC AND ADULT STUDY SUBJECTSâ€?DEVELOPMENT ISSUES RELATED TO ORGAN DEVELOPMENT AND ENDPOINT CHOICES25 Brain and Central Nervous System Development: Physiological Considerations for Assessment of Long-Term Safety -- 26 Cognitive Development Considerations for Long-Term Safety Exposures in Children -- 27 Cardiovascular and QTc Issues -- 28 Renal Function Issues -- 29 Growth and Physical Maturation -- PART VII CLINICAL TRIAL OPERATIONS AND GOOD CLINICAL TRIALS 
520 |a 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 u. 
546 |a English. 
590 |a ProQuest Ebook Central  |b Ebook Central Academic Complete 
650 0 |a Pediatric pharmacology. 
650 0 |a Drug development. 
650 0 |a Children. 
650 0 |a Age factors in disease. 
650 0 |a Drugs  |x Design. 
650 2 |a Child 
650 2 |a Drug Evaluation  |x methods 
650 2 |a Age Factors 
650 2 |a Clinical Trials as Topic  |x standards 
650 2 |a Drug Design 
650 2 |a Drug Evaluation  |x ethics 
650 2 |a Drug Evaluation  |x standards 
650 6 |a Pharmacologie pédiatrique. 
650 6 |a Médicaments  |x Développement. 
650 6 |a Enfants. 
650 6 |a Maladies  |x Facteurs liés à l'âge. 
650 6 |a Médicaments  |x Conception. 
650 7 |a children (people by age group)  |2 aat 
650 7 |a MEDICAL  |x Drug Guides.  |2 bisacsh 
650 7 |a MEDICAL  |x Pharmacology.  |2 bisacsh 
650 7 |a MEDICAL  |x Pharmacy.  |2 bisacsh 
650 7 |a MEDICAL  |x Nursing  |x Pharmacology.  |2 bisacsh 
650 7 |a Drugs  |x Design  |2 fast 
650 7 |a Children  |2 fast 
650 7 |a Age factors in disease  |2 fast 
650 7 |a Drug development  |2 fast 
650 7 |a Pediatric pharmacology  |2 fast 
700 1 |a Mulberg, Andrew E. 
700 1 |a Silber, Steven A. 
700 1 |a Van den Anker, John N. 
776 0 8 |i Print version:  |t Pediatric drug development.  |d Hoboken, N.J. : John Wiley, ©2009  |z 9780470169292  |w (DLC) 2008019010  |w (OCoLC)226949963 
856 4 0 |u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=573760  |z Texto completo 
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