Abstract
Introduction from the Editors The Editors Authors' Short Biographies Authors' Addresses Europe's Path towards Better Medicines for Children: Ramet, J. Rose, K. The European Academy of Paediatrics (EAP/CESP) and Its Demand for More Clinical Research: Ramet, J. van den Anker, J.N. Paediatric Medicines: A View from Patient Organisations: Kent, A. Oosterwijk, C. Schyns, T. Poortman, Y. Paediatric Drug Development - Historical Background of Regulatory Initiatives: Stotter, H. ICH E 11: Clinical Investigation of Medicinal Products in the Paediatric Population. The International Guidance on Clinical Drug Development in Children: Rose, K. Stotter, H. Ethical Challenges of Clinical Research in Children. Protection from Risks vs. Access to Benefits: Neubauer, D. Laitinen-Parkkonen, P. Matthys, D. Consent and Assent in Paediatric Clinical Trials: Lamprill, J. Fowler, P.A. Collecting Blood and Tissue Samples in Paediatric Clinical Trials: Furst-Recktenwald, S. Soergel, M. Paediatric Formulations: Breitkreutz, J. Tuleu, C. Solomonidou, D. Central Laboratory in Paediatric Clinical Trials: Henry, M.M. Study and Protocol Design for Paediatric Patients of Different Ages: Della Pasqua, O. Zimmerhackl, L.-B. Rose, K. Innovative Methodologies for Drug Evaluation in Children: Pons, G. van den Anker, J.N. Challenges in the Research of Very Small Children: van den Anker, J.N. Ramet, J. Clinical Research for Infant Nutrition: Steenhout, P. Ziegler, E.E. Conclusions: Paediatric Drug Development in a Global Context: Maldonado, S. van den Anker, J.N. Rose, K..
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