| Description |
1 online resource (xx, 683 pages) : illustrations |
| Contents |
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 |
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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 |
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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 |
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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 |
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PART VI CLINICAL TRIAL OPERATIONS: UNDERSTANDING DIFFERENCES BETWEEN PEDIATRIC AND ADULT STUDY SUBJECTS�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 |
| Summary |
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 |
| Bibliography |
Includes bibliographical references and index |
| Notes |
English |
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Print version record |
| Subject |
Pediatric pharmacology.
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Drug development.
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Children.
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Age factors in disease.
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Drugs -- Design.
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Child
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Drug Evaluation -- methods
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Age Factors
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Clinical Trials as Topic -- standards
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Drug Design
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Drug Evaluation -- ethics
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Drug Evaluation -- standards
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children (people by age group)
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MEDICAL -- Drug Guides.
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MEDICAL -- Pharmacology.
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MEDICAL -- Pharmacy.
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MEDICAL -- Nursing -- Pharmacology.
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Drugs -- Design
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Children
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Age factors in disease
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Drug development
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Pediatric pharmacology
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| Form |
Electronic book
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| Author |
Mulberg, Andrew E
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Silber, Steven A
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Van den Anker, John N
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| LC no. |
2008019010 |
| ISBN |
0470930489 |
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9780470930489 |
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9781118210437 |
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1118210433 |
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1283915561 |
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9781283915564 |
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