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Volumn 469, Issue 2, 2014, Pages 260-262

More than 5 years of European Paediatric Regulation: Statistics and industrial experience

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG; DRUG DOSAGE FORM;

EID: 84902271428     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2014.03.058     Document Type: Article
Times cited : (7)

References (13)
  • 1
    • 33846316714 scopus 로고    scopus 로고
    • Paediatric and geriatric drug delivery
    • DOI 10.1517/17425247.4.1.37
    • J. Breitkreutz, and J. Boos Paediatric and geriatric drug delivery Expert Opinion on Drug Delivery 4 2007 37 45 (Pubitemid 46117485)
    • (2007) Expert Opinion on Drug Delivery , vol.4 , Issue.1 , pp. 37-45
    • Breitkreutz, J.1    Boos, J.2
  • 2
    • 25844468887 scopus 로고    scopus 로고
    • Reflection paper: formulation of choice for the paediatric population. (assessed 08.12.13.)
    • Committee for Medicinal Products for Human Use, EMA, 2006: Reflection paper: formulation of choice for the paediatric population (http://www.ema. europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003782. pdf). (assessed 08.12.13.).
    • (2006) Committee for Medicinal Products for Human Use, EMA
  • 5
    • 84902289872 scopus 로고    scopus 로고
    • EFPIA survey on impact of the paediatric regulation on marketing authorization holders (Jan 2007-June 2010)
    • (assessed 08.12.13.)
    • Creba, J., Johnson, C., Joos, A., 2011. EFPIA survey on impact of the paediatric regulation on marketing authorization holders (Jan 2007-June 2010). EMA-EFPIA information day (http://www.ema.europa.eu/docs/en-GB/document-library/ Presentation/2011/05/WC500106718.pdf). (assessed 08.12.13.).
    • (2011) EMA-EFPIA Information Day
    • Creba, J.1    Johnson, C.2    Joos, A.3
  • 11
    • 78650192442 scopus 로고    scopus 로고
    • Juvenile animal studies for the development of paediatric medicines: A description and conclusions from a European medicines agency workshop on juvenile animal testing for nonclinical assessors
    • B.S. Lima, M.D. Theilade-Thomsen, J. Carleer, J.M. Vidal, P. Tomasi, and A. Saint-Raymond Juvenile animal studies for the development of paediatric medicines: a description and conclusions from a European medicines agency workshop on juvenile animal testing for nonclinical assessors Birth Defects Research 89 2010 467 473
    • (2010) Birth Defects Research , vol.89 , pp. 467-473
    • Lima, B.S.1    Theilade-Thomsen, M.D.2    Carleer, J.3    Vidal, J.M.4    Tomasi, P.5    Saint-Raymond, A.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.