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Volumn 350, Issue , 2015, Pages

The secret realm of phase I trials in healthy volunteers

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO;

EID: 84939219905     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.h3444     Document Type: Editorial
Times cited : (4)

References (8)
  • 1
    • 35248865300 scopus 로고    scopus 로고
    • Why healthy subjects volunteer for phase I studies and how they perceive their participation?
    • Almeida L, Azevedo B, Nunes T, et al. Why healthy subjects volunteer for phase I studies and how they perceive their participation? Eur J Clin Pharmacol 2007; 63: 1085-94.
    • (2007) Eur J Clin Pharmacol , vol.63 , pp. 1085-1094
    • Almeida, L.1    Azevedo, B.2    Nunes, T.3
  • 2
    • 33748416499 scopus 로고    scopus 로고
    • Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412
    • Suntharalingam G, Perry MR, Ward S, et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med 2006; 355: 1018-28.
    • (2006) N Engl J Med , vol.355 , pp. 1018-1028
    • Suntharalingam, G.1    Perry, M.R.2    Ward, S.3
  • 3
    • 0142089747 scopus 로고    scopus 로고
    • Fatal systemic inflammatory response syndrome in a ornithine transcarbamylase deficient patient following adenoviral gene transfer
    • Raper SE, Chirmule N, Lee FS, et al. Fatal systemic inflammatory response syndrome in a ornithine transcarbamylase deficient patient following adenoviral gene transfer. Mol Genet Metab 2003; 80: 148-58.
    • (2003) Mol Genet Metab , vol.80 , pp. 148-158
    • Raper, S.E.1    Chirmule, N.2    Lee, F.S.3
  • 4
    • 61449092661 scopus 로고    scopus 로고
    • Inadequate dissemination of phase I trials: A retrospective cohort study
    • Decullier E, Chan AW, Chapuis F. Inadequate dissemination of phase I trials: a retrospective cohort study. PLoS Med 2009; 6: e1000034.
    • (2009) PLoS Med , vol.6
    • Decullier, E.1    Chan, A.W.2    Chapuis, F.3
  • 5
    • 84880650385 scopus 로고    scopus 로고
    • Giving monoclonal antibodies to healthy volunteers in phase 1 trials: Is it safe?
    • Tranter E, Peters G, Boyce M, et al. Giving monoclonal antibodies to healthy volunteers in phase 1 trials: is it safe? Br J Clin Pharmacol 2013; 76: 164-72.
    • (2013) Br J Clin Pharmacol , vol.76 , pp. 164-172
    • Tranter, E.1    Peters, G.2    Boyce, M.3
  • 6
    • 40449134704 scopus 로고    scopus 로고
    • Food and drug administration amendments act of 2007
    • US Congress. Food and Drug Administration Amendments Act of 2007. Public Law 2007: 115-85.
    • (2007) Public Law , pp. 115-185
  • 7
    • 84926288672 scopus 로고    scopus 로고
    • Accessibility of trial reports for drugs stalling in development: A systematic assessment of registered trials
    • Hakala A, Kimmelman J, Carlisle B, et al. Accessibility of trial reports for drugs stalling in development: a systematic assessment of registered trials. BMJ 2015; 350: h1116.
    • (2015) BMJ , vol.350
    • Hakala, A.1    Kimmelman, J.2    Carlisle, B.3
  • 8
    • 84939222174 scopus 로고    scopus 로고
    • Quantifying the risks of non-oncology phase I research in healthy volunteers: Meta-analysis of phase I studies
    • Emanuel EJ, Bedarida G, Macci K, et al. Quantifying the risks of non-oncology phase I research in healthy volunteers: meta-analysis of phase I studies. BMJ 2015; 350: h3271.
    • (2015) BMJ , vol.350
    • Emanuel, E.J.1    Bedarida, G.2    Macci, K.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.