Guide to paediatric clinical research
By: editors, Klaus Rose, John N. van den Anker.
Contributors: Rose, Klaus, 1953-; Van den Anker, John N.
Publisher: Karger
Published: 2007
Place of publication: Basel; New York
Language: eng
Number of pages: 137
ISBN-13: 9783805582018
Subjects: Pediatrics -- Research.; Clinical medicine -- Research.; Children -- Research -- Moral and ethical aspects.; Pediatrics.; Research Design.; Clinical Trials -- standards.; Drug Evaluation -- methods.; Ethics, Research.; Risk Assessment.
Other titles: Guide to pediatric clinical research
Notes: Includes bibliographical references and indexes.
Table of 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.