-
1
-
-
77958499413
-
-
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
-
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
-
3
-
-
80052869080
-
Manufacture of advanced therapies: academia meets industry
-
Sethe S., Batkai C., Dickinson A., Hildebrandt M. Manufacture of advanced therapies: academia meets industry. Regulatory Rapporteur 2011, 8:7-8.
-
(2011)
Regulatory Rapporteur
, vol.8
, pp. 7-8
-
-
Sethe, S.1
Batkai, C.2
Dickinson, A.3
Hildebrandt, M.4
-
5
-
-
46249120116
-
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
-
-
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
-
-
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
-
9
-
-
33748416499
-
Cytokine storm in a phase I trial of the anti-CD28 monoclonal antibody TGN1412
-
Suntharalingam G., Perry M.R., Ward S., Brett S.J., Castello-Cortes A., Brunner M.D., Panoskaltis N. Cytokine storm in a phase I trial of the anti-CD28 monoclonal antibody TGN1412. NEngl J Med 2006, 355:1018-1028.
-
(2006)
NEngl J Med
, vol.355
, pp. 1018-1028
-
-
Suntharalingam, G.1
Perry, M.R.2
Ward, S.3
Brett, S.J.4
Castello-Cortes, A.5
Brunner, M.D.6
Panoskaltis, N.7
-
10
-
-
84862626037
-
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
-
-
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)
-
-
|