| Contents |
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. ... [et al.] -- Paediatric drug development: historical background of regulatory initiatives / Statter, H. -- ICH E 11: clinical investigation of medicinal products in the paediatric population. The international guidance on clinical drug development in children / Rose, K., Statter, 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, 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. |
