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Guide to Paediatric Clinical Research
About this book
As off-label use of medicines in children is no longer acceptable today, paediatric drug development is currently in transition from an almost exclusive academic specialty towards an integrated part of the global process that drives the development of new pharmaceuticals. US and EU governments have made it mandatory for the pharmaceutical industry to investigate medicines in children, thus exposing a multitude of different institutions to paediatric research. Written by exponents of the academia as well as the pharmaceutical industry, regulators and patient advocacy groups, this book explains the background of the US and EU paediatric legislations, gives an analysis of their probable short-, mid- and long-term impact, addresses key operational challenges in paediatric research, and develops a tentative vision where paediatric drug development needs to go. Helping to understand the role of the different stakeholders, the spectrum of readers to profit from this book ranges from paediatricians, general medical personnel and pharmacologists to those involved in regulatory affairs and clinical trials, pharmaceutical company management, patient advocacy groups, ethical committees, politicians and interested lay persons.
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Information
Table of contents
- Cover
- Contents
- Introduction from the Editors
- The Editors
- Authors’ Short Biographies
- Authors’ Addresses
- Europe’s Path towards Better Medicines for Children
- The European Academy of Paediatrics (EAP/ CESP) and Its Demand for More Clinical Research
- Paediatric Medicines: A View from Patient Organisations
- Paediatric Drug Development – Historical Background of Regulatory Initiatives
- ICH E 11: Clinical Investigation of Medicinal Products in the Paediatric Population: The International Guidance on Clinical Drug Development in Children
- Ethical Challenges of Clinical Research in Children
- Consent and Assent in Paediatric Clinical Trials
- Collecting Blood and Tissue Samples in Paediatric Clinical Trials
- Paediatric Formulations
- Central Laboratory in Paediatric Clinical Trials
- Study and Protocol Design for Paediatric Patients of Different Ages
- Innovative Methodologies for Drug Evaluation in Children
- Challenges in the Research of Very Small Children
- Clinical Research for Infant Nutrition
- Conclusions: Paediatric Drug Development in a Global Context
- Author Index
- Subject Index