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Guide to paediatric drug development and clinical research

Author: Klaus Rose; John N Van den Anker
Publisher: Basel ; New York : Karger, ©2010.
Edition/Format:   Print book : EnglishView all editions and formats
Summary:

Children in the developed world have never enjoyed better medical care: mortality has decreased and many fatal diseases of the past can today be prevented or even cured.

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Genre/Form: Aufsatzsammlung
Material Type: Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: Klaus Rose; John N Van den Anker
ISBN: 9783805593625 3805593627 9783805593632 3805593635
OCLC Number: 498977891
Description: xx, 221 pages : illustrations ; 26 cm
Contents: Machine generated contents note: The Global Framework of Paediatric Drug Development --
Europe and the Path to Better Medicines for Children / Rose, K. --
European Union Paediatric Regulation: Theory and Practice / Rose, K. --
United States Paediatric Legislation Impact on Paediatric Drug Studies / Maldonado, S. --
Facilitation of Paediatric Research in Japan / Ozaki, M. --
Ethical Imperatives in Medical Research on Child Subjects-Reflections of a Past President of the World Medical Association / Appleyard, W.J. --
Paediatric Clinical Research: The Patients' Perspective / Poortman, Y. --
Providing Global Access to Essential Medicines for Children --
The WHO Better Medicines for Children Programme / Hill, S. --
Paediatric Clinical Pharmacology --
Paediatric Clinical Pharmacology: From Bench to Bedside / Van den Anker, J.N. --
Role of Clinical Pharmacology in the Development of Paediatric Clinical Development Plans / Liogier d'Ardhuy, X. --
Practical and Ethical Challenges Note continued: Guides through the EMA Paediatric Website / Della Pasqua, O. --
Paediatric Homework: Paediatric Investigation Plan Key Elements / Della Pasqua, O. --
Ethics in Paediatric Research: Three Years after the Introduction of the European Regulation / Rose, K. --
Consent and Assent in Paediatric Clinical Trials / Fowler, P.A. --
Study and Protocol Design for Paediatric Patients of Different Ages / Rose, K. --
Points to Consider when Planning the Collection of Blood or Tissue Samples in Clinical Trials of Investigational Medicinal Products in Children, Infants and Neonates / Turner, M.A. --
General and Specific Scientific Challenges --
What Constitutes Adequate Strength of Evidence? / Day, S. --
Paediatric Formulations / Breitkreutz, J. --
The Future of Oral Paediatric Formulations / Bar-Shalom, D. --
Paediatric Pharmacovigilance in Clinical Research and Drug Development / Day, S. Note continued: Role of Non-Clinical Safety Assessment in Paediatric Drug Development / De Schaepdrijver, L.M. --
Paediatric Critical Care / Nadel, S. --
Disease-Specific Challenges --
Research and Drug Development in Paediatric Oncology / Pritchard-Jones, K. --
Paediatric Cancer Treatment in Africa / Renner, L.A. --
Paediatric Clinical Research in Immunology and Inflammation / Gay, S. --
Clinical Trials of Anti-Infective Agents in Paediatrics / Friedland, I. --
Obesity in Children / Hebebrand, J. --
Familial Dyslipidaemia in Children / Wiegman, A. --
Paediatric Anti-Hypertensive Clinical Trials and Various Factors Influencing Trial Success or Failure / Portman, R.J. --
Paediatric Vaccination Trials / Vesikari, T. --
Future of the Paediatric Pharmaceutical Market --
Future of the Paediatric Pharmaceutical Market / Rose, K.
Other Titles: Guide to pediatric drug development and clinical research
Responsibility: editors, Klaus Rose, John N. van den Anker.

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