Drug policy in Europe. Research and funding in neonates: Current challenges, future perspectives, new opportunities

Early Human Development

Volumn 87, Issue SUPPL., 2011, Pages

  Jacqz Aigrain, Evelyne ^a  

^a INSERM   (France)

Author keywords

[No Author keywords available]

Indexed keywords

AZITHROMYCIN; CIPROFLOXACIN; FLUCONAZOLE;

ARTICLE; DRUG SURVEILLANCE PROGRAM; FUNDING; GESTATIONAL AGE; HEALTH CARE POLICY; HUMAN; LAW; MEDICAL ETHICS; MEDICAL RESEARCH; NEWBORN CARE; PREMATURITY;

ADULT; CLINICAL TRIALS AS TOPIC; DRUG AND NARCOTIC CONTROL; EUROPE; HUMANS; INFANT, NEWBORN; INFANT, NEWBORN, DISEASES; NEONATOLOGY; PEDIATRICS; RESEARCH;

EID: 79951813948     PISSN: 03783782     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.earlhumdev.2011.01.007     Document Type: Article

References (17)

1. t Jong G.W., et al. 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.
2. Conroy S., et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children. BMJ 2000, 320:79-82.
3. The Paediatric Regulation http://eur-lex.europa.eu.
4. Jacqz-Aigrain E., Lassale C. La politique du médicament pour l'enfant en France et en Europe: enjeux et difficultés. Arch Pédiatr 2009, 16:661-663.
5. Kearns G.L., Abdel-Rahman S.M., Alander S.W., Blowey D.L., Leeder J.S., Kauffman R.E. Developmental pharmacology-drug disposition, action, and therapy in infants and children. N Engl J Med 2003, 18(349):1157-1167.
6. Koren G. Therapeutic drug monitoring principles in the neonate. National Academy of Clinical Biochemistry. Clin Chem 1997, 43:222-227.
7. Guideline on the investigation of medicinal products in the term and preterm neonate. Committee for médicinal products for human use (CHMP) and paediatric committee (PDCO) January 2009, http://www.emea.europa.eu.
8. ICHE11: International Conference of Harmonization of technical requirements for registration of pharmaceutical for human use. ICH. Harmonised tripartite Guideline. Clinical Investigation of Medicinal Products in the paediatric population http://www.ich.org/LOB/media/MEDIA487.pdf.
9. Guideline on the need for non-clinical testing in juvenile animals on human pharmaceuticals for paediatric indications 2005.
10. Reflection paper: formulations of choice for the paediatric population 2005, http://www.emea.europa.eu.
11. Wong I.C., Wong L.Y., Cranswick N.E. Minimising medication errors in children. Arch Dis Child 2009, 94:161-164. Epub 2008 Oct 1.
12. Johnson T.N., Rostami-Hodjegan A., Tucker G.T. Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children. Clin Pharmacokinet 2006, 45:931-956.
13. Ethical considerations for clinical trials on medicinal products with the paediatric population. Recommendations of the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use 2008, http://www.emea.europa.eu.
14. Donnelly F. Paediatric medicines and the health theme in the co-operation programme of FP7 http://www.emea.europa.eu/docs/en_GB/document_library/presentation/2009.
15. Rocchi F., Paolucci P., Ceci A., Rossi P. The European paediatric legislation: benefits and perspectives. Ital J Pediatr 2010, 66:1091-1097. (Epub 2010 Sep 7).
16. Règlement Européen sur les médicaments pédiatriques: surveiller son application. La revue Prescrire. 289;289 :858-862.
17. Davies E.H., Ollivier C.M., Saint Raymond A. Paediatric investigation plans for pain: painfully slow. Eur J Clin Pharmacol 2010, 17:36-56.