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Volumn 205, Issue , 2011, Pages 111-124

Development of paediatric medicines: Concepts and principles

Author keywords

Historical context of paediatric drug development; Incentives for paediatric clinical research; Medicines for children; Neglected diseases; Paediatric drug development; Priorities in paediatric drug development; Public health; Regulatory authorities

Indexed keywords

ARTICLE; CLINICAL DEVELOPMENT PLAN; DRUG EFFICACY; DRUG INDUSTRY; DRUG LABELING; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG SAFETY; DRUG UTILIZATION; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HEALTH CARE NEED; HEALTH CARE POLICY; HUMAN; MEDICAL DECISION MAKING; MEDICAL INFORMATION; MEDICAL PRACTICE; OFF LABEL DRUG USE; PEDIATRIC MEDICINE; PEDIATRICS; PERSONALIZED MEDICINE; PHARMACEUTICAL CARE; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROSPECTIVE STUDY; PUBLIC HEALTH; PUBLIC-PRIVATE PARTNERSHIP; RETROSPECTIVE STUDY; REWARD;

EID: 80054949958     PISSN: 01712004     EISSN: 18650325     Source Type: Book Series    
DOI: 10.1007/978-3-642-20195-0_5     Document Type: Article
Times cited : (11)

References (15)
  • 1
    • 77956605206 scopus 로고    scopus 로고
    • What is the right dose for children?
    • doi:10.1111/j.1365-2125.2009.03591.x
    • Cella M, Knibbe C, Danhof M, Della Pasqua O (2010) What is the right dose for children? Br J Clin Pharmacol 70:597-603. doi:10.1111/j.1365-2125.2009. 03591.x
    • (2010) Br J Clin Pharmacol , vol.70 , pp. 597-603
    • Cella, M.1    Knibbe, C.2    Danhof, M.3    Della Pasqua, O.4
  • 2
    • 84858003143 scopus 로고    scopus 로고
    • DNDi (Drugs for Neglected Diseases Initiative), Accessed 14 Oct 2010
    • DNDi (Drugs for Neglected Diseases Initiative) (2010) http://www.dndi.org. Accessed 14 Oct 2010
    • (2010)
  • 3
    • 84858007324 scopus 로고    scopus 로고
    • European Medicines Agency, Accessed 14 Oct 2010
    • European Medicines Agency (2010) http://www.ema.europa.eu. Accessed 14 Oct 2010
    • (2010)
  • 4
    • 84858006974 scopus 로고    scopus 로고
    • FDA (Food and Drug Administration), Accessed 14 Oct 2010
    • FDA (Food and Drug Administration) (2010) http://www.fda.gov. Accessed 14 Oct 2010
    • (2010)
  • 5
    • 84858006975 scopus 로고    scopus 로고
    • FDAAA (FDA Amendment Acts), Accessed 14 Oct 2010
    • FDAAA (FDA Amendment Acts) (2010) http://www.fda.gov/ RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/ SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/ default.htm. Accessed 14 Oct 2010
    • (2010)
  • 6
    • 84858003144 scopus 로고    scopus 로고
    • Gates Foundation, Accessed 14 Oct 2010
    • Gates Foundation (2010) http://www.gatesfoundation.org. Accessed 14 Oct 2010
    • (2010)
  • 8
    • 84858007326 scopus 로고    scopus 로고
    • ICH, International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. Accessed 14 Oct 2010
    • ICH (2010) International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. http://www.ich.org. Accessed 14 Oct 2010
    • (2010)
  • 9
    • 84858006972 scopus 로고    scopus 로고
    • ICH E11, ICH tripartite guideline: Clinical investigation of medicinal products in the pediatric population, Accessed 14 Oct 2010
    • ICH E11 (2010) ICH tripartite guideline: Clinical investigation of medicinal products in the pediatric population. http://www.ich.org/LOB/media/ MEDIA487.pdf. Accessed 14 Oct 2010
    • (2010)
  • 10
    • 84858007325 scopus 로고    scopus 로고
    • MMV (Medicines for Malaria Venture), Accessed 14 Oct 2010
    • MMV (Medicines for Malaria Venture) (2010) http://www.mmv.org. Accessed 14 Oct 2010
    • (2010)
  • 11
    • 80051947519 scopus 로고    scopus 로고
    • Karger, Basel, Switzerland, Accessed 14 Oct 2010. ISBN 978- 3-8055-9362-5; e-ISBN: 978-3-8055-9363-2
    • Rose K, van den Anker J (eds) (2010) Guide to paediatric drug development and clinical research. Karger, Basel, Switzerland, http://content.karger.com/ ProdukteDB/produkte.asp?Aktion=showproducts&searchWhat=books&ProduktNr= 253804. Accessed 14 Oct 2010. ISBN 978- 3-8055-9362-5; e-ISBN: 978-3-8055-9363-2
    • (2010) Guide to Paediatric Drug Development and Clinical Research
    • Rose, K.1    Van Den Anker, J.2
  • 12
    • 52449110548 scopus 로고    scopus 로고
    • Paediatric drug development: Historical background of regulatory initiatives
    • In: Rose K, van den Anker JN (eds), Karger, Basel
    • Stoetter H (2007) Paediatric drug development: Historical background of regulatory initiatives. In: Rose K, van den Anker JN (eds) Guide to paediatric clinical research. Karger, Basel, pp 25-32
    • (2007) Guide to Paediatric Clinical Research , pp. 25-32
    • Stoetter, H.1
  • 13
    • 73849164353 scopus 로고
    • A study of the German outbreak of phocomelia
    • Taussig HB (1962) A study of the German outbreak of phocomelia. JAMA 180(32):1106-1114
    • (1962) JAMA , vol.180 , Issue.32 , pp. 1106-1114
    • Taussig, H.B.1
  • 14
    • 0029644362 scopus 로고
    • Elixirs, diluents, and the passage of the 1938 Federal Food, Drug and Cosmetic Act
    • Wax P (1995) Elixirs, diluents, and the passage of the 1938 Federal Food, Drug and Cosmetic Act. Ann Intern Med 122:456-461
    • (1995) Ann Intern Med , vol.122 , pp. 456-461
    • Wax, P.1
  • 15
    • 84858006973 scopus 로고    scopus 로고
    • WHO, Accessed 14 Oct 2010
    • WHO (2010) http://www.who.int. Accessed 14 Oct 2010
    • (2010)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.