FREE ELECTRONIC LIBRARY - Books, dissertations, abstract

Pages:     | 1 |   ...   | 5 | 6 ||

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

-- [ Page 7 ] --

- 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;


- 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

–  –  –

Pages:     | 1 |   ...   | 5 | 6 ||

Similar works:

«Aus dem Physiologischen Institut der Universität Würzburg Lehrstuhl für Physiologie – Schwerpunkt vegetative Physiologie Vorstand: Prof. Dr. M. Kuhn Mechanismus der schnellen Geninduktion von Egr-1 durch Östrogen am Herzen: Ein Steroidhormon geht neue Wege Inaugural-Dissertation zur Erlangung der Doktorwürde der Medizinischen Fakultät der Julius-Maximilians-Universität zu Würzburg vorgelegt von Stephan Müller-Botz aus Würzburg Würzburg, im Juni 2010 Referent: Prof. Dr. rer. nat. K....»

«HP Data Replication Solution Service for 3PAR Virtual Copy HP Care Pack Services Technical data HP Data Replication Solution Service for 3PAR Virtual Copy provides implementation of the HP 3PAR Storage System's Virtual Copy product. This service provides the analysis, design, implementation, and testing services necessary to deploy Virtual Copy functionality. Virtual Copy provides enhanced availability and disaster recovery protection. To help ensure a timely, cost-effective deployment that...»

«Kriege – Informationssammler Human Security Report www.humansecurityreport.info SIPRI – Stockholmer Internationale Institut für Friedensforschung SIPRI Jahresbericht 2004 Bild der Wissenschaft – Themenschwerpunkt in Heft 4/2006 Mathias Horx – Der gute Krieg Ziad Oberneyer-Studie (Zahl der Kriegstoten – Analyse für World Health Survey) – http://www.bmj.com/cgi/content/full/bmj.a137 http://www.spiegel.de/wissenschaft/mensch/0,1518,560688,00.html Kriege seit 1956 im Sudan...»

«Courts Apply the Doctrine of Equitable Estoppel to Prevent Employers from Skirting Liability for their Actions Toward Otherwise Ineligible Employees Contributed by: Kris D. Meade and Christopher P. Calsyn1, Crowell & Moring LLP Several federal courts have recently wrestled with the thorny issue of whether or not to apply equitable estoppel principles to extend Family Medical Leave Act (“FMLA”) protections to otherwise ineligible employees. In most cases, these courts have acknowledged...»

«TABLE OF CONTENTS Emergency Contacts 2 Introduction 3 The International Center 4 The University of Utah On-campus Housing 10 Medical Care and Health Insurance 11 Student Health Service Quick Reference 17 Student Health Service Checklist for Medical Visits 18 Safety & Security 19 Campus Resources 20 Campus Facilities 23 School Activities 24 U of U Holidays and Vacations 27 Salt Lake City 28 Off-Campus Housing 28 Installing Utilities 31 Shopping 32 Banking 37 Postal Service 41 Local...»

<<  HOME   |    CONTACTS
2016 www.book.dislib.info - Free e-library - Books, dissertations, abstract

Materials of this site are available for review, all rights belong to their respective owners.
If you do not agree with the fact that your material is placed on this site, please, email us, we will within 1-2 business days delete him.