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Volumn 16, Issue 3, 2014, Pages 289-297

Regulation of advanced therapy medicinal products in Europe and the role of academia

Author keywords

Advanced therapy medicinal products; European Union; Good manufacturing practice; Manufacturing; Regulation

Indexed keywords

ADVANCED THERAPY MEDICINAL PRODUCTS; EUROPEAN UNION; GOOD MANUFACTURING PRACTICE; MANUFACTURING; REGULATION;

EID: 84895170844     PISSN: 14653249     EISSN: 14772566     Source Type: Journal    
DOI: 10.1016/j.jcyt.2013.08.003     Document Type: Article
Times cited : (63)

References (11)
  • 1
    • 77958499413 scopus 로고    scopus 로고
    • Regulation (EC) No. 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No. 726/2004
    • Regulation (EC) No. 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No. 726/2004. Official Journal of the European Union. 2007;L 324:121-131.
    • (2007) Official Journal of the European Union , vol.324 L , pp. 121-131
  • 2
    • 84857756807 scopus 로고    scopus 로고
    • Clinical development of advanced therapy medicinal products in Europe: evidence that regulators must be proactive
    • Maciulaitis R., D'Apote L., Buchanan A., Pioppo L., Schneider C.K. Clinical development of advanced therapy medicinal products in Europe: evidence that regulators must be proactive. Mol Ther 2012, 20:483-512.
    • (2012) Mol Ther , vol.20 , pp. 483-512
    • Maciulaitis, R.1    D'Apote, L.2    Buchanan, A.3    Pioppo, L.4    Schneider, C.K.5
  • 5
    • 46249120116 scopus 로고    scopus 로고
    • Multiple correspondence analysis
    • Sage, Thousand Oaks, California, N. Salkind (Ed.)
    • Abdi H., Valentin D. Multiple correspondence analysis. Encyclopaedia of Measurement and Statistics 2007, Sage, Thousand Oaks, California. N. Salkind (Ed.).
    • (2007) Encyclopaedia of Measurement and Statistics
    • Abdi, H.1    Valentin, D.2
  • 6
    • 84895171388 scopus 로고    scopus 로고
    • A Practical Guide to the Use of Correspondence Analysis in Marketing Research. Marketing Bulletin, 14, Technical Note 2.
    • Bendixen M. A Practical Guide to the Use of Correspondence Analysis in Marketing Research. Marketing Bulletin, 14, Technical Note 2. 2003. http://marketing-bulletin.massey.ac.nz/V14/MB_V14_T2_Bendixen.pdf.
    • (2003)
    • Bendixen, M.1
  • 8
    • 84895175536 scopus 로고    scopus 로고
    • Biplots in Practice. Available free on-line.
    • Greenacre M. Biplots in Practice. Available free on-line. http://www.multivariatestatistics.org/publications.html.
    • Greenacre, M.1
  • 10
    • 84862626037 scopus 로고    scopus 로고
    • Use of one-off, compassionate use, advanced therapy medicinal products (ATMP) as a safe and valid alternative to animal models for pre-clinical data for clinical trial submissions?
    • Lowdell M.W., Birchall M., Thrasher A.J. Use of one-off, compassionate use, advanced therapy medicinal products (ATMP) as a safe and valid alternative to animal models for pre-clinical data for clinical trial submissions?. Lancet 2012, 379:2341.
    • (2012) Lancet , vol.379 , pp. 2341
    • Lowdell, M.W.1    Birchall, M.2    Thrasher, A.J.3
  • 11
    • 84895141747 scopus 로고    scopus 로고
    • Clinical data may, in part, compensate for non-clinical studies; inappropriate animal studies are worse than reliance upon in vitro data only." Dr Christian Schneider, Chair of EMA Committee for Advanced Therapies at ATMP Stakeholders' Workshop, EMA, London, January'
    • "Clinical data may, in part, compensate for non-clinical studies; inappropriate animal studies are worse than reliance upon in vitro data only." Dr Christian Schneider, Chair of EMA Committee for Advanced Therapies at ATMP Stakeholders' Workshop, EMA, London, January 2012. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2011/11/event_detail_000545.jsp&mid=WC0b01ac058004d5c3.
    • (2012)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.