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Volumn 11, Issue 2, 2007, Pages 123-127

Better medicines for children: Clinical investigation of medicinal products in the paediatric population - A QA perspective

Author keywords

Children medicines; Paediatric investigational plan; Paediatric research

Indexed keywords

CHILD; CLINICAL RESEARCH; EUROPE; HUMAN; INTERNATIONAL COOPERATION; LAW; MEDICAL ETHICS; PEDIATRICS; POPULATION RESEARCH; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; RISK ASSESSMENT;

EID: 40349096333     PISSN: 10878378     EISSN: 10991786     Source Type: Journal    
DOI: 10.1002/qaj.422     Document Type: Review
Times cited : (2)

References (13)
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  • 2
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  • 3
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    • Hood S et al. Children as research subjects: A risky enterprise. Children and Society 1996; 2: 117-128.
    • (1996) Children and Society , vol.2 , pp. 117-128
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  • 4
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    • The geography of children: Some ethical and methodological considerations for project and dissertation work
    • Matthews H et al. The geography of children: Some ethical and methodological considerations for project and dissertation work. Journal of Geography in Higher Education 1998; 3: 311-324.
    • (1998) Journal of Geography in Higher Education , vol.3 , pp. 311-324
    • Matthews, H.1
  • 8
    • 20644469453 scopus 로고    scopus 로고
    • Better medicines for children - where we are now, where do we want to be?
    • Rose K. Better medicines for children - where we are now, where do we want to be? British Journal of Clinical Pharmacology 2005; 6: 657-659.
    • (2005) British Journal of Clinical Pharmacology , vol.6 , pp. 657-659
    • Rose, K.1
  • 9
    • 40349105047 scopus 로고    scopus 로고
    • International Conference on Harmonization. ICH E11 - Clinical Investigation of Medicinal Products in the Pediatric Population, Step 4, 20 July 2000. Available at: http://www.ich.org/LOB/media/MEDIA487.pdf
    • International Conference on Harmonization. ICH E11 - Clinical Investigation of Medicinal Products in the Pediatric Population, Step 4, 20 July 2000. Available at: http://www.ich.org/LOB/media/MEDIA487.pdf
  • 10
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    • Regulation (EC) No. 1901/2006 of the European Parliament and of the Council of 12 December 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. OJ L 378, 1-19. Available at: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/1/reg_2006_1901/ reg_2006_1901_en.pdf
    • Regulation (EC) No. 1901/2006 of the European Parliament and of the Council of 12 December 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. OJ L 378, 1-19. Available at: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/reg_2006_1901/ reg_2006_1901_en.pdf
  • 11
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    • International Conference on Harmonization. ICH E5(R1) - Ethnic Factors in the Acceptability of Foreign Clinical Data, Step 4, 5 February 1998. Available at: http://www.ich.org/LOB/media/MEDIA481.pdf
    • International Conference on Harmonization. ICH E5(R1) - Ethnic Factors in the Acceptability of Foreign Clinical Data, Step 4, 5 February 1998. Available at: http://www.ich.org/LOB/media/MEDIA481.pdf
  • 13
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    • US Pediatric Research Equity Act PREA, Available at
    • US Pediatric Research Equity Act (PREA). 2003. Available at: http://www.fda.gov/cder/pediatric/index.htm
    • (2003)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.