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03067cam a22004334a 4500 001 1059AD366BF311DEA13FF332A8D7520A 003 SILO 005 20090730151022 008 060922s2007 sz a b 001 0 eng 010 $a 2006031666 020 $a 9783805582018 (hardcover : alk. paper) 020 $a 3805582013 (hardcover : alk. paper) 020 $a 3805582013 (hard cover : alk. paper) 020 $a 9783805582018 (hard cover : alk. paper) 040 $a DNLM/DLC $c DLC $d SILO $d BAKER $d OHX $d BTCTA $d YDXCP $d C#P $d OCLCG $d IWO $d SILO 042 $a pcc 050 00 $a RJ85 $b .G85 2007 082 00 $a 618.92 $2 22 245 0 $a Guide to paediatric clinical research / $c editors, Klaus Rose, John N. van den Anker. 246 3 $a Guide to pediatric clinical research 260 $a New York : $b Karger, $c 2007. 300 $a xxvi, 137 p. : $b ill. ; $c 25 cm. 504 $a Includes bibliographical references and indexes. 505 0 $a 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. 650 0 $a Pediatrics $x Research. 650 0 $a Clinical medicine $x Research. 650 0 $a Children $x Moral and ethical aspects. $x Moral and ethical aspects. 650 12 $a Pediatrics. 650 12 $a Research Design. 650 22 $a Clinical Trials as Topic $x standards. 650 22 $a Drug Evaluation $x methods. 650 22 $a Ethics, Research. 650 22 $a Risk Assessment. 700 1 $a Rose, Klaus, $d 1953- 700 1 $a Van den Anker, John N. 941 $a 1 952 $l OVUX522 $d 20180102055427.0 956 $a http://locator.silo.lib.ia.us/search.cgi?index_0=id&term_0=1059AD366BF311DEA13FF332A8D7520A 994 $a 02 $b IWOInitiate Another SILO Locator Search