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«ETHICAL CONSIDERATIONS FOR CLINICAL TRIALS PERFORMED IN CHILDREN Recommendations of the Ad hoc group for the development of implementing guidelines ...»

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- March J, Kratochvil C, Clarke G, Beardslee W, Derivan A, Emslie G, et al. AACAP 2002 Research Forum: Placebo and alternatives to placebo in randomized controlled trials in pediatric psychopharmacology. J Am Acad Child Adolesc Psychiatry 2004; 43: 1046-1056.

- EMEA/CPMP Position statement on the use of placebo in clinical trials with regard to the revised Declaration of Helsinki. http://www.emea.eu.int/pdfs/human/press/pos/1742401en.pdf

27.8 Publications on drug development and monitoring in children

- ‘t Jong GW, Stricker BH, Choonara I, van den Anker JN. Lack of effect of European guidance on clinical investigation of medicines in children. Acta Paediatr. 2002;91:1233-8.

- Alexander D. The PPRU network of the NIHCH HD. Drug Information Journal 1999;33:385-91.

- Turner S, Nunn A J, Fielding K et al. Adverse drug reactions to unlicensed and off label drugs on paediatric wards: a prospective study. Acta Paediatr 1999; 88: 965-968.

- Conroy S, Choonara I, Impicciatore P et al. Survey of unlicensed and off label drug use in paediatric wards in European Countries. Europeans Network for Drug Investigation in Children. BMJ 2000;

320:79-82.

- Horen B, Montastruc J L, Lapeyre-Mestre M. Adverse drug reactions and off label drug use in paediatric outpatients. Br J Clin Pharmacol 2002; 54: 665-670.

McIntyre J Conroy S, Avery A, Corns H, Choonara I. Unlicensed and off-label prescribing of drugs in general practice. Arch Dis Child 2000; 83: 498-501

- ‘t Jong G W, van den Linden P D, Bakker E M, van der Lely n, Eland I A, Stricker B H van den Anker J N. Unlicensed and off label drug use in a paediatric ward of a general hospital in the Netherlands. Eur J Clin Pharmacol 2002; 58: 293-297.

- Conroy S, Newman c, Gudka S. Unlicensed and off-label drug use in acute lymphoblastic leukaemia and other malignancies in children. Ann Oncol 2003;14:1-5.

–  –  –

- Conroy S, McIntyre J, Choonara I, Stephenson T. Drug trials in children: problems and the way forward. Br J Clin Pharmacol 2000; 49: 93-97

- Lietman PS. Chloramphenicol and the neonate – 1979 view. Clin Perinatol 1979 : 6:151-162

- Bartels H. Drug therapy in childhood: what has been done and what has to be done? Pediatr Pharmacol 1983;3:131-143

- Roberts R, Rodriguez W, Murphy D, Crescenzi T. Pediatric drug labeling: improving the safety and efficacy of pediatric therapies. JAMA 2003; 290: 905-911.

- Ginsberg G, Hattis D, Sonawane B, Russ A, Banati P Kozlak M et al. Evaluation of child/adult pharmacokinetic differences from a database derived from the therapeutic drug literature. Toxicol Sci 2002;66:185-200.

- Konstan MW, Byard PJ, Hoppel CL, Davis PB. Effect of high dose ibuprofen in patients with cystic fibrosis. N Engl J Med 1995: 332:848-854.

- Arranz I, Martin-Suarez A, Lanao JM, Mora F, Vasquez C, Escribano A, et al. Population pharmacokinetics of high does ibuprofen in cystic fibrosis. Arch Dis Child 2003;88:1128-1130.

- Knorr B, Larson P, Nguyen HH, Holland S, Reiss TF, Chervinsky P, et al. Montelukast dose selection in children 6 to 14 year-olds: comparison of single-dose pharmacokinetics in children and adults. J Clin Pharmacol 1999;39:786-793.

- Knorr B, Nguyen HH, Kearns GL, Villaran C, Boza ML, Reiss TF, et al. Montelukast dose selection in children ages 2 to 5 years: comparison of population pharmacokinetics between children and adults.

J Clin Pharmacol 2001;41:612-619.

- Cresteil T. Onset of xenobiotic metabolism in children: toxicological implications. Food Addit Contam 1998:15S:45-51.

- International Pharmaceutical Federation. FIP statement of principle: Pharmaceutical research in paediatric patients. Date unknown

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