The Resource Pediatric drug development : concepts and applications, edited by Andrew E. Mulberg, Steven A. Silber, John N. van den Anker

Pediatric drug development : concepts and applications, edited by Andrew E. Mulberg, Steven A. Silber, John N. van den Anker

Label
Pediatric drug development : concepts and applications
Title
Pediatric drug development
Title remainder
concepts and applications
Statement of responsibility
edited by Andrew E. Mulberg, Steven A. Silber, John N. van den Anker
Contributor
Subject
Language
eng
Cataloging source
N$T
Dewey number
615/.190083
Illustrations
illustrations
Index
index present
LC call number
RJ560
LC item number
.P3875 2009eb
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
Label
Pediatric drug development : concepts and applications, edited by Andrew E. Mulberg, Steven A. Silber, John N. van den Anker
Publication
Antecedent source
unknown
Bibliography note
Includes bibliographical references and index
http://library.link/vocab/branchCode
  • net
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
txt
Content type MARC source
rdacontent
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""
  • ""18 Absorption, Distribution, Metabolism, and Excretion (ADME) and Pharmacokinetic Assessments in Juvenile Animals""""PART 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""
  • ""7 Industry Benchmarks in Pediatric Clinical Trials""""8 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""
  • ""PART III REGULATORY GUIDELINES FOR PEDIATRIC DRUG DEVELOPMENT: STIMULATION OF PEDIATRIC DRUG RESEARCH BY REGULATORY AUTHORITIES""""12 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""
  • ""PART VI CLINICAL TRIAL OPERATIONS: UNDERSTANDING DIFFERENCES BETWEEN PEDIATRIC AND ADULT STUDY SUBJECTSâ€?DEVELOPMENT ISSUES RELATED TO ORGAN DEVELOPMENT AND ENDPOINT CHOICES""""25 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""
Control code
ocn664571178
Dimensions
unknown
Extent
1 online resource (xx, 683 pages)
File format
unknown
Form of item
online
Isbn
9781118210437
Level of compression
unknown
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other physical details
illustrations
Quality assurance targets
not applicable
http://library.link/vocab/recordID
.b35959253
Reformatting quality
unknown
Sound
unknown sound
Specific material designation
remote
System control number
  • (OCoLC)664571178
  • pebcs0470930489

Library Locations

    • Deakin University Library - Geelong Waurn Ponds CampusBorrow it
      75 Pigdons Road, Waurn Ponds, Victoria, 3216, AU
      -38.195656 144.304955
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