Biomedical Engineering Reference
In-Depth Information
Opinion on the State of the Art concerning Tissue Engineering. Adopted by the scientific
committee on medicinal products and medical devices on 1st October 2002
Doc.
sanco/scmPmD/2001/0006Final, http://ec.europa.eu/health/ph_risk/committees/
scmp/documents/out37_en.pdf.
european commission. enterprise and industry Directorate-general. consumer
goods. Pharmaceuticals (2006),
detailed Guidance on the Application format and
documentation to be submitted in an Application for an Ethics Committee Opinion on
the Clinical Trial on Medicinal products for human Use. Revision 1.
enTr/cT2, http://
ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/12_ec_guideline_20060216.
pdf.
european group on ethics (2004),
Report of the European group on Ethics on the Ethical
Aspects of human Tissue Engineered products,
http://ec.europa.eu/european_group_
ethics/docs/humantissueprod_en.pdf.
european Parliament (2007), 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 (Text with
eea relevance), http://eur-lex.europa.eu/LexUriserv/LexUriserv.do?uri=oJ:L:2007:
324:0121:0137:en:PDF.
Faden r, Dawson L, Bateman-House a, mueller agnew D, Bok H, Brock D, chakravarti
a, gao x.-J, greene m, Hansen J, King P, o'Brien s, sachs D, schill K, siegel a,
solter D, suter s, Verfaillie c, Walters L and gearhart J (2003), 'Public stem cell
banks: considerations of justice in stem cell research and therapy',
hastings Cent
Rep
,
33
, 13-27.
Farrugia a (2006), 'When do tissues and cells become products? regulatory oversight
of emerging biological therapies',
Cell Tissue Bank
,
7
(4), 325-35.
Flory J and emanuel e (2004), 'interventions to improve research participants' understanding
in informed consent for research: a systematic review',
JAMA
,
292
, 1593-601.
Freedman B (1987), 'equipoise and the ethics of clinical research',
N Engl J Med
,
317
(3), 141-5.
giannoni P, crovace a, malpeli m, maggi e, arbico r, cancedda r and Dozin B (2005),
'species variability in the differentiation potential of
in vitro
-expanded articular
chondrocytes restricts predictive studies on cartilage repair using animal models',
Tissue Eng
,
11
(1/2), 237-48.
gordijn B (2004),
Medizinische Utopien. Eine ethische Betrachtung,
Vandenhoeck and
ruprecht, göttingen.
Halme D and Kessler D (2006), 'FDa regulation of stem-cell-based therapies',
N Engl
J Med
,
355
(16), 1730-35.
Healy L, Hunt c, Young L and stacey g (2005), 'The UK stem cell Bank: its role as a
public research resource centre providing access to well-characterised seed stocks of
human stem cell lines',
Adv drug deliv Rev
,
57
(13), 1981-8.
Hollander A, Dickinson S, Sims T, Brun P, Cortivo R, Kon E, Marcacci M, Zanasi S,
Borrione a, De Luca c, Pavesio a, soranzo c and abatangelo g (2006), 'maturation
of tissue engineered cartilage implanted in injured and osteoarthritic human knees',
Tissue Eng
,
12
(7), 1787-98.
Hutchison c, cowan c, mcmahon T and Paul J (2007), 'a randomised controlled study
of an audiovisual patient information intervention in informed consent and recruitment
to cancer clinical trials',
Br J Cancer
,
97
, 705-11.
Jakobsen r, engebretsen L. and slauterbeck J (2005), 'an analysis of the quality of
cartilage repair studies',
J Bone Joint Surg Am
,
87
, 2232-9.
