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Volumn 161, Issue 4, 2013, Pages 301-307

Better medicines for children: What has been achieved by the EU Paediatric Regulation after 5 years?;Bessere Arzneimittel für Kinder: Wie viel hat die "paediatric Regulation" der EU nach 5 Jahren erreicht?

Author keywords

Authorization; Children; Clinical trial; Drugs; Pediatric regulation

Indexed keywords

ARTICLE; CHILD HEALTH CARE; DRUG APPROVAL; DRUG DESIGN; DRUG INDICATION; DRUG INDUSTRY; PHARMACEUTICAL CARE; RISK BENEFIT ANALYSIS;

EID: 84879902759     PISSN: 00269298     EISSN: 14330474     Source Type: Journal    
DOI: 10.1007/s00112-012-2791-5     Document Type: Article
Times cited : (2)

References (25)
  • 2
    • 84879987016 scopus 로고    scopus 로고
    • European Commission European Commission, Brüssel Zugegriffen: 15.01.2013
    • European Commission (2012) FP7 cooperation work programme: health 2013. European Commission, Brüssel. ftp://ftp.cordis.europa.eu/pub/fp7/health/ docs/fp7-health-wp-2013-en.pdf. Zugegriffen: 15.01.2013
    • (2012) FP7 Cooperation Work Programme: Health 2013.
  • 3
    • 84879974627 scopus 로고    scopus 로고
    • European Commission (no 19012006), 'experience acquired' and 'lessons learnt' submitted for public consultation European Commission, Brüssel Zugegriffen: 15.01.2013
    • European Commission (2012) General report on experience acquired as a result of the application of the Paediatric Regulation (no 1901/2006), 'experience acquired' and 'lessons learnt' submitted for public consultation. European Commission, Brüssel. http://ec.europa.eu/health/files/paediatrics/ 2012-09-publicconsultation-en.pdf. Zugegriffen: 15.01.2013
    • (2012) General Report on Experience Acquired As A Result of the Application of the Paediatric Regulation
  • 4
    • 84879944261 scopus 로고    scopus 로고
    • European Medicines Agency EMA, London Zugegriffen: 15.01.2013
    • European Medicines Agency (2007) Inventory of paediatric needs. EMA, London. http://www.emea.europa.eu/htms/human/paediatrics/inventory.htm. Zugegriffen: 15.01.2013
    • (2007) Inventory of Paediatric Needs
  • 6
    • 84870748473 scopus 로고    scopus 로고
    • European Medicines Agency EMA, London. Zugegriffen: 15.01.2013
    • European Medicines Agency (2011) EU clinical trials register. EMA, London. https://www.clinicaltrialsregister.eu/index.htm. Zugegriffen: 15.01.2013
    • (2011) EU Clinical Trials Register
  • 9
    • 84879952655 scopus 로고    scopus 로고
    • European Medicines Agency EMA, London. Zugegriffen: 15.01.2013
    • European Medicines Agency (2012) Paediatric workshops. EMA, London. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/ general-content-000416.jsp&mid=WC0b01ac0580118a19. Zugegriffen: 15.01.2013
    • (2012) Paediatric Workshops
  • 10
    • 84879954846 scopus 로고    scopus 로고
    • European Medicines Agency EMA, London. Zugegriffen: 15.01.2013
    • European Medicines Agency (2012) PDCO monthly report, December 2012. EMA, London. http://www.emea.europa.eu/docs/en-GB/document-library/Committee- meeting-report/2012/12/WC500136450.pdf. Zugegriffen: 15.01.2013
    • (2012) PDCO Monthly Report, December 2012
  • 11
    • 84879964872 scopus 로고    scopus 로고
    • European Medicines Agency Zugegriffen: 15.01.2013
    • European Medicines Agency (2013) Opinions on paediatric investigation plans. EMA, London. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/ landing/pip-search.jsp&mid=WC0b01ac058001d129. Zugegriffen: 15.01.2013
    • (2013) Opinions on Paediatric Investigation Plans. EMA, London
  • 13
    • 77649201713 scopus 로고    scopus 로고
    • European Medicines Agency EMA, London. Zugegriffen: 15.01.2013
    • European Medicines Agency (2013) Revised priority list for studies into off-patent paediatric medicinal products. EMA, London. http://www.ema.europa.eu/ docs/en-GB/document-library/Other/2009/10/WC500004017.pdf. Zugegriffen: 15.01.2013
    • (2013) Revised Priority List for Studies into Off-patent Paediatric Medicinal Products
  • 14
    • 79955150798 scopus 로고    scopus 로고
    • Regulation (EC) No 1901/2006 and 1902/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use. Paediatric regulation
    • European Parliament and Council
    • European Parliament and Council (2006) Regulation (EC) No 1901/2006 and 1902/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use. Paediatric regulation. Official J Eur Union 18:L378/1
    • (2006) Official J Eur Union , vol.18
  • 15
    • 0036904363 scopus 로고    scopus 로고
    • Adverse drug reactions and off-label drug use in paediatric outpatients
    • Horen B, Montastruc J, Lapeyre-Mestre M (2002) Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol 54:665-670
    • (2002) Br J Clin Pharmacol , vol.54 , pp. 665-670
    • Horen, B.1    Montastruc, J.2    Lapeyre-Mestre, M.3
  • 16
    • 20644445856 scopus 로고    scopus 로고
    • Modelling approaches to dose estimation in children
    • Johnson TN (2005) Modelling approaches to dose estimation in children. Br J Clin Pharmacol 59(6):663-669
    • (2005) Br J Clin Pharmacol , vol.59 , Issue.6 , pp. 663-669
    • Johnson, T.N.1
  • 17
    • 0141857724 scopus 로고    scopus 로고
    • Developmental pharmacology: Drug disposition, action, and therapy in infants and children
    • Kearns GL, Abdel-Rahman SM, Alander SW et al (2003) Developmental pharmacology: drug disposition, action, and therapy in infants and children. N Engl J Med 349:1157-1167
    • (2003) N Engl J Med , vol.349 , pp. 1157-1167
    • Kearns, G.L.1    Abdel-Rahman, S.M.2    Alander, S.W.3
  • 18
    • 65549126411 scopus 로고    scopus 로고
    • Off-label and unlicensed drug prescribing in three paediatric wards in Finland and review of the international literature
    • Lindell-Osuagwu L, Korhonen MJ, Saano S et al (2009) Off-label and unlicensed drug prescribing in three paediatric wards in Finland and review of the international literature. J Clin Pharm Ther 34:277-287
    • (2009) J Clin Pharm Ther , vol.34 , pp. 277-287
    • Lindell-Osuagwu, L.1    Korhonen, M.J.2    Saano, S.3
  • 19
    • 79955593514 scopus 로고    scopus 로고
    • Healthcare professional experiences and attitudes on unlicensed/off-label paediatric prescribing and paediatric clinical trials
    • Mukattash T, Hawwa AF, Trew K, McElnay JC (2011) Healthcare professional experiences and attitudes on unlicensed/off-label paediatric prescribing and paediatric clinical trials. Eur J Clin Pharmacol 67:449-461
    • (2011) Eur J Clin Pharmacol , vol.67 , pp. 449-461
    • Mukattash, T.1    Hawwa, A.F.2    Trew, K.3    McElnay, J.C.4
  • 21
    • 0036607366 scopus 로고    scopus 로고
    • Unlicensed and off-label prescription of drugs to children: A population based cohort study
    • 'T Jong GW, Eland IA, Sturkenboom MC et al (2002) Unlicensed and off-label prescription of drugs to children: a population based cohort study. BMJ 324:1313-1314
    • (2002) BMJ , vol.324 , pp. 1313-1314
    • 'T Jong, G.W.1    Eland, I.A.2    Sturkenboom, M.C.3
  • 22
    • 0030043616 scopus 로고    scopus 로고
    • Use of 'off-label' and unlicensed drugs in paediatric intensive care unit
    • Turner S, Gill A, Nunn T et al (1996) Use of 'off-label' and unlicensed drugs in paediatric intensive care unit. Lancet 347:549-550
    • (1996) Lancet , vol.347 , pp. 549-550
    • Turner, S.1    Gill, A.2    Nunn, T.3
  • 23
    • 0032869076 scopus 로고    scopus 로고
    • Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: A prospective study
    • Turner S, Nunn AJ, Fielding K, Choonara I (1999) Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: a prospective study. Acta Paediatr 88:965-968
    • (1999) Acta Paediatr , vol.88 , pp. 965-968
    • Turner, S.1    Nunn, A.J.2    Fielding, K.3    Choonara, I.4
  • 24
    • 84879993040 scopus 로고    scopus 로고
    • United States Food and Drug Administration FDA, Silver Spring Zugegriffen: 15.01.2013
    • United States Food and Drug Administration (2007) Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA). FDA, Silver Spring. http://www.fda.gov/downloads/Drugs/ DevelopmentApprovalProcess/ DevelopmentResources/UCM049870.pdf. Zugegriffen: 15.01.2013
    • (2007) Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA)
  • 25
    • 0032887329 scopus 로고    scopus 로고
    • An update on the therapeutic orphan
    • Wilson JT (1999) An update on the therapeutic orphan. Pediatrics 104:585-590
    • (1999) Pediatrics , vol.104 , pp. 585-590
    • Wilson, J.T.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.