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Volumn 30, Issue 11, 2008, Pages 2146-2154

European perspectives on pediatric formulations

Author keywords

drug formulations; European Union; pediatrics; regulations

Indexed keywords

ARTICLE; CHILD CARE; DRUG DOSAGE FORM; DRUG FORMULATION; DRUG INDUSTRY; DRUG RESEARCH; EUROPEAN UNION; HEALTH CARE POLICY; MEDICAL SOCIETY; TASTE ACUITY; UNITED STATES; WORLD HEALTH ORGANIZATION;

EID: 57849084850     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2008.11.016     Document Type: Article
Times cited : (64)

References (48)
  • 1
    • 57849093182 scopus 로고    scopus 로고
    • US Food and Drug Administration. FDA's information on the Modernization Act of 1997.
    • US Food and Drug Administration. FDA's information on the Modernization Act of 1997.
  • 2
    • 57849165517 scopus 로고    scopus 로고
    • Accessed
    • (November 19, 2008). http://www.fda.gov/cdrh/modact/modern.html Accessed
    • (2008)
  • 3
    • 20244368931 scopus 로고    scopus 로고
    • Survey of unlicensed and off label drug use in paediatric wards in European countries
    • for the European Network for Drug Investigation in Children
    • Conroy S., Choonara I., Impicciatore P., et al., for the European Network for Drug Investigation in Children. Survey of unlicensed and off label drug use in paediatric wards in European countries. BMJ 320 (2000) 79-82
    • (2000) BMJ , vol.320 , pp. 79-82
    • Conroy, S.1    Choonara, I.2    Impicciatore, P.3
  • 5
    • 57849140239 scopus 로고    scopus 로고
    • Regulation (EC) No. 1901/2006 of the European Parliament and of the Council of December 12, 2006, on medicinal products for paediatric use and amending Regulation (EEC) No. 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No. 726/2004.
    • Regulation (EC) No. 1901/2006 of the European Parliament and of the Council of December 12, 2006, on medicinal products for paediatric use and amending Regulation (EEC) No. 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No. 726/2004.
  • 6
    • 57849105546 scopus 로고    scopus 로고
    • Accessed
    • (November 11, 2008). http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:378:0001 :0019:EN:PDF Accessed
    • (2008)
  • 7
    • 57849107234 scopus 로고    scopus 로고
    • European Union institutions and other bodies.
    • European Union institutions and other bodies.
  • 8
    • 57849164141 scopus 로고    scopus 로고
    • Accessed
    • (November 11, 2008). http://europa.eu/institutions/index_en.htm Accessed
    • (2008)
  • 9
    • 57849146140 scopus 로고    scopus 로고
    • European Commission. Notice to applicants. Vol. 2A. Procedures for marketing authorisation. Chapter 2. Mutual recognition.
    • European Commission. Notice to applicants. Vol. 2A. Procedures for marketing authorisation. Chapter 2. Mutual recognition.
  • 10
    • 57849137950 scopus 로고    scopus 로고
    • Accessed
    • (November 11, 2008). http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/a/vol2a_ch ap2_2005-11.pdf Accessed
    • (2008)
  • 11
    • 57849129422 scopus 로고    scopus 로고
    • Rote Liste Service GmbH, Frankfurt, Germany
    • Rote Liste 2008 (2008), Rote Liste Service GmbH, Frankfurt, Germany
    • (2008) Rote Liste 2008
  • 12
  • 13
    • 35449007558 scopus 로고    scopus 로고
    • European legislation to improve medicines for children
    • Choonara I., and Bonati M. European legislation to improve medicines for children. Paed Perinat Drug Ther 8 (2007) 2-3
    • (2007) Paed Perinat Drug Ther , vol.8 , pp. 2-3
    • Choonara, I.1    Bonati, M.2
  • 14
    • 57849150029 scopus 로고    scopus 로고
    • ICH Topic E 11: Clinical investigation of medicinal products in the paediatric population (CPMP/ICH/2711/99).
    • ICH Topic E 11: Clinical investigation of medicinal products in the paediatric population (CPMP/ICH/2711/99).
  • 15
    • 57849093635 scopus 로고    scopus 로고
    • Accessed
    • (November 11, 2008). http://www.emea.europa.eu/pdfs/human/ich/271199en.pdf Accessed
    • (2008)
  • 16
    • 57849114911 scopus 로고    scopus 로고
    • Committee for Medicinal Products for Human Use (CHMP). Reflection paper: Formulations of choice for the paediatric population.
    • Committee for Medicinal Products for Human Use (CHMP). Reflection paper: Formulations of choice for the paediatric population.
  • 17
    • 57849134263 scopus 로고    scopus 로고
    • Accessed
    • (November 11, 2008). http://www.emea.europa.eu/pdfs/human/paediatrics/19481005en.pdf Accessed
    • (2008)
  • 18
    • 1642534652 scopus 로고    scopus 로고
    • Lack of appropriate formulations of medicines for children in the community
    • Schirm E., Tobi H., de Vries T.W., et al. Lack of appropriate formulations of medicines for children in the community. Acta Paediatr 92 (2003) 1486-1489
    • (2003) Acta Paediatr , vol.92 , pp. 1486-1489
    • Schirm, E.1    Tobi, H.2    de Vries, T.W.3
  • 19
    • 28844462985 scopus 로고    scopus 로고
    • When do children convert from liquid antiretroviral to solid formulations?
    • Yeung V.W., and Wong I.C. When do children convert from liquid antiretroviral to solid formulations?. Pharm World Sci 27 (2005) 399-402
    • (2005) Pharm World Sci , vol.27 , pp. 399-402
    • Yeung, V.W.1    Wong, I.C.2
  • 20
    • 3242687759 scopus 로고    scopus 로고
    • Inhaler devices in infants and children: Challenges and sol utions
    • Everard M.L. Inhaler devices in infants and children: Challenges and sol utions. J Aerosol Med 17 (2004) 186-195
    • (2004) J Aerosol Med , vol.17 , pp. 186-195
    • Everard, M.L.1
  • 21
    • 33846316714 scopus 로고    scopus 로고
    • Paediatric and geriatric drug delivery
    • Breitkreutz J., and Boos J. Paediatric and geriatric drug delivery. Expert Opin Drug Deliv 4 (2007) 37-45
    • (2007) Expert Opin Drug Deliv , vol.4 , pp. 37-45
    • Breitkreutz, J.1    Boos, J.2
  • 22
    • 34547944987 scopus 로고    scopus 로고
    • Developing paediatric medicines: Identifying the needs and recogniz ing the challenges
    • Ernest T.B., Elder D.P., Martini L.G., et al. Developing paediatric medicines: Identifying the needs and recogniz ing the challenges. J Pharm Pharmacol 59 (2007) 1043-1055
    • (2007) J Pharm Pharmacol , vol.59 , pp. 1043-1055
    • Ernest, T.B.1    Elder, D.P.2    Martini, L.G.3
  • 23
    • 47949109452 scopus 로고    scopus 로고
    • Activities of the PDCO [in German]
    • Throm S. Activities of the PDCO [in German]. Pharm Ind 70 (2008) 729
    • (2008) Pharm Ind , vol.70 , pp. 729
    • Throm, S.1
  • 24
    • 57849093181 scopus 로고    scopus 로고
    • Pediatric Research EquityAct(2003).
    • Pediatric Research EquityAct(2003).
  • 25
    • 57849167158 scopus 로고    scopus 로고
    • Accessed
    • (November 11, 2008). http://frwebgate.access.gpo.gov/cgibin/getdoc.cgi?dbname=108_cong_ public_laws&docid=f:publ155.108 Accessed
    • (2008)
  • 26
    • 33947432894 scopus 로고    scopus 로고
    • New regulation of children's medicines
    • Martin A. New regulation of children's medicines. Pharm Technol Eur 19 (2007) 19-20
    • (2007) Pharm Technol Eur , vol.19 , pp. 19-20
    • Martin, A.1
  • 27
    • 57849155846 scopus 로고    scopus 로고
    • European Medicines Agency (EMEA). Recommendation of the Paediatric Committee to the European Com mission regarding the symbol (December 20, 2007), EMEA/498247/2007.
    • European Medicines Agency (EMEA). Recommendation of the Paediatric Committee to the European Com mission regarding the symbol (December 20, 2007), EMEA/498247/2007.
  • 28
    • 57849141302 scopus 로고    scopus 로고
    • Accessed
    • (November 21, 2008). http://www.emea.europa.eu/pdfs/human/paediatrics/49824707en.pdf Accessed
    • (2008)
  • 29
    • 57849104698 scopus 로고    scopus 로고
    • European Commission (EC). Commission at present not in a position to select a symbol for medicines authorised for a paediatric indication (January 30, 2008).
    • European Commission (EC). Commission at present not in a position to select a symbol for medicines authorised for a paediatric indication (January 30, 2008).
  • 30
    • 57849113589 scopus 로고    scopus 로고
    • Accessed
    • (November 11, 2008). http://ec.europa.eu/enterprise/pharmaceuticals/paediatrics/medchild_key_ en.htm Accessed
    • (2008)
  • 31
    • 57849106000 scopus 로고    scopus 로고
    • European Medicines Agency (EMEA). The network of paediatric networks at the EMEA implementing strategy (January 15, 2008). EMEA/MB/543523/2007.
    • European Medicines Agency (EMEA). The network of paediatric networks at the EMEA implementing strategy (January 15, 2008). EMEA/MB/543523/2007.
  • 32
    • 57849156557 scopus 로고    scopus 로고
    • Accessed
    • (November 21, 2008). http://www.emea.europa.eu/pdfs/human/paediatrics/54352307en.pdf Accessed
    • (2008)
  • 33
    • 57849153553 scopus 로고    scopus 로고
    • European Medicines Agency (EMEA). Medicines for children: Paediatric needs.
    • European Medicines Agency (EMEA). Medicines for children: Paediatric needs.
  • 34
    • 57849099717 scopus 로고    scopus 로고
    • Accessed
    • (November 11, 2008). http://www.emea.europa.eu/htms/human/paediatrics/inventory.htm Accessed
    • (2008)
  • 35
    • 57849165880 scopus 로고    scopus 로고
    • European Medicines Agency (EMEA). Revised priority list for studies into off-patent paediatric medicinal products, EMEA/226983/2008.
    • European Medicines Agency (EMEA). Revised priority list for studies into off-patent paediatric medicinal products, EMEA/226983/2008.
  • 36
    • 57849096703 scopus 로고    scopus 로고
    • Accessed
    • (November 21, 2008). http://www.emea.europa.eu/pdfs/human/paediatrics/22698308en.pdf Accessed
    • (2008)
  • 37
    • 40449102971 scopus 로고    scopus 로고
    • Improving drug delivery in pediatric medicine
    • Krause J., and Breitkreutz J. Improving drug delivery in pediatric medicine. Pharm Med 22 (2008) 41-50
    • (2008) Pharm Med , vol.22 , pp. 41-50
    • Krause, J.1    Breitkreutz, J.2
  • 38
    • 0036083807 scopus 로고    scopus 로고
    • Issues in the formulation of drugs for oral use in children: Role of excipients
    • Pawar S., and Kumar A. Issues in the formulation of drugs for oral use in children: Role of excipients. Paediatr Drugs 4 (2002) 371-379
    • (2002) Paediatr Drugs , vol.4 , pp. 371-379
    • Pawar, S.1    Kumar, A.2
  • 39
    • 0022260575 scopus 로고
    • "Inactive" ingredients in pharmaceutical products. Committee on Drugs
    • American Academy of Pediatrics. "Inactive" ingredients in pharmaceutical products. Committee on Drugs. Pediatrics 76 (1985) 635-643
    • (1985) Pediatrics , vol.76 , pp. 635-643
    • American Academy of Pediatrics1
  • 40
    • 57849158293 scopus 로고    scopus 로고
    • European Medicines Agency (EMEA). Medicines for children: Scientific guidance.
    • European Medicines Agency (EMEA). Medicines for children: Scientific guidance.
  • 41
    • 57849109970 scopus 로고    scopus 로고
    • Accessed
    • (November 11, 2008). http://www.emea.europa.eu/htms/human/paediatrics/sci_gui.htm Accessed
    • (2008)
  • 42
    • 57849123265 scopus 로고    scopus 로고
    • European Medicines Agency (EMEA). Medicines for children: Global cooperations: Workshops.
    • European Medicines Agency (EMEA). Medicines for children: Global cooperations: Workshops.
  • 43
    • 57849138535 scopus 로고    scopus 로고
    • Accessed
    • (November 11, 2008). http://www.emea.europa.eu/htms/human/paediatrics/workshops.htm Accessed
    • (2008)
  • 44
    • 53549113627 scopus 로고    scopus 로고
    • Publishing the evidence for children's medicine
    • Choonara I., and Bauchner H. Publishing the evidence for children's medicine. Arch Dis Child 93 (2008) 815
    • (2008) Arch Dis Child , vol.93 , pp. 815
    • Choonara, I.1    Bauchner, H.2
  • 45
    • 0032696576 scopus 로고    scopus 로고
    • Dosage forms for peroral drug administration to children
    • Breitkreutz J., Wessel T., and Boos J. Dosage forms for peroral drug administration to children. Paed Perin Drug Ther 3 (1999) 25-33
    • (1999) Paed Perin Drug Ther , vol.3 , pp. 25-33
    • Breitkreutz, J.1    Wessel, T.2    Boos, J.3
  • 46
    • 49449096542 scopus 로고    scopus 로고
    • How long does it take to administer oral medicines to children?
    • Skwierczynski C., and Conroy S. How long does it take to administer oral medicines to children?. Paed Perin Drug Ther 8 (2008) 145-149
    • (2008) Paed Perin Drug Ther , vol.8 , pp. 145-149
    • Skwierczynski, C.1    Conroy, S.2
  • 47
    • 0003304194 scopus 로고    scopus 로고
    • Extemporaneous formulations-problems and solutions
    • Woods D.J. Extemporaneous formulations-problems and solutions. Paed Perin Drug Ther 1 (1997) 25-29
    • (1997) Paed Perin Drug Ther , vol.1 , pp. 25-29
    • Woods, D.J.1
  • 48
    • 57849104472 scopus 로고    scopus 로고
    • Cram A, Breitkreutzj, Desset-Brèthes S, et al, on behalf of the European Paediatric Formulation Initiative. Challenges of developing palatable oral paediatric formulations [published online ahead of print September 19, 2008]. Intj Pharm.
    • Cram A, Breitkreutzj, Desset-Brèthes S, et al, on behalf of the European Paediatric Formulation Initiative. Challenges of developing palatable oral paediatric formulations [published online ahead of print September 19, 2008]. Intj Pharm.


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