Ethical Review;
Good Clinical Practice;
Medical Institution;
Pharmaceutical Product;
Bioethic Committee;
D O I:
10.1007/BF03256732
中图分类号:
学科分类号:
摘要:
This article examines the current Ukrainian approach to creating a national infrastructure for medicines advancement and human subjects protection through clinical trials based on good clinical practice (GCP). It explores the roles of the government, the healthcare society, ethics committees and industry in contributing to the development of a national infrastructure that contributes to national needs in health research as well as the global development of medicines.
机构:
Natl Canc Ctr, Breast & Med Oncol Div, Dept Breast & Med Oncol, Chuo Ku, Tokyo 1030045, JapanNatl Canc Ctr, Breast & Med Oncol Div, Dept Breast & Med Oncol, Chuo Ku, Tokyo 1030045, Japan
Yonemori, K.
Hirakawa, A.
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Tokyo Univ Sci, Grad Sch Engn, Dept Management Sci, Tokyo 162, JapanNatl Canc Ctr, Breast & Med Oncol Div, Dept Breast & Med Oncol, Chuo Ku, Tokyo 1030045, Japan
Hirakawa, A.
Ando, M.
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机构:
Natl Canc Ctr, Dept Clin Trial Coordinat & Dev Therapeut, Tokyo 1030045, JapanNatl Canc Ctr, Breast & Med Oncol Div, Dept Breast & Med Oncol, Chuo Ku, Tokyo 1030045, Japan
Ando, M.
Hirata, T.
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机构:Natl Canc Ctr, Breast & Med Oncol Div, Dept Breast & Med Oncol, Chuo Ku, Tokyo 1030045, Japan
Hirata, T.
Shimizu, C.
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机构:Natl Canc Ctr, Breast & Med Oncol Div, Dept Breast & Med Oncol, Chuo Ku, Tokyo 1030045, Japan
Shimizu, C.
Katsumata, N.
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机构:Natl Canc Ctr, Breast & Med Oncol Div, Dept Breast & Med Oncol, Chuo Ku, Tokyo 1030045, Japan
Katsumata, N.
Tamura, K.
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机构:Natl Canc Ctr, Breast & Med Oncol Div, Dept Breast & Med Oncol, Chuo Ku, Tokyo 1030045, Japan
Tamura, K.
Fujiwara, Y.
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机构:
Natl Canc Ctr, Dept Clin Trial Coordinat & Dev Therapeut, Tokyo 1030045, JapanNatl Canc Ctr, Breast & Med Oncol Div, Dept Breast & Med Oncol, Chuo Ku, Tokyo 1030045, Japan
机构:
Duke Clin Res Inst, POB 17969, Durham, NC 27715 USA
Duke Univ, Med Ctr, Dept Med, Div Cardiol, Durham, NC 27710 USADuke Clin Res Inst, POB 17969, Durham, NC 27715 USA
Mentz, Robert J.
Hernandez, Adrian F.
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机构:
Duke Clin Res Inst, POB 17969, Durham, NC 27715 USA
Duke Univ, Med Ctr, Dept Med, Div Cardiol, Durham, NC 27710 USADuke Clin Res Inst, POB 17969, Durham, NC 27715 USA
Hernandez, Adrian F.
Berdan, Lisa G.
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机构:
Duke Clin Res Inst, POB 17969, Durham, NC 27715 USADuke Clin Res Inst, POB 17969, Durham, NC 27715 USA
Berdan, Lisa G.
Rorick, Tyrus
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机构:
Duke Clin Res Inst, POB 17969, Durham, NC 27715 USADuke Clin Res Inst, POB 17969, Durham, NC 27715 USA
Rorick, Tyrus
O'Brien, Emily C.
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机构:
Duke Clin Res Inst, POB 17969, Durham, NC 27715 USA
Duke Univ, Med Ctr, Dept Med, Div Cardiol, Durham, NC 27710 USADuke Clin Res Inst, POB 17969, Durham, NC 27715 USA
O'Brien, Emily C.
Ibarra, Jenny C.
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h-index: 0
机构:
Duke Clin Res Inst, POB 17969, Durham, NC 27715 USADuke Clin Res Inst, POB 17969, Durham, NC 27715 USA
Ibarra, Jenny C.
Curtis, Lesley H.
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机构:
Duke Clin Res Inst, POB 17969, Durham, NC 27715 USADuke Clin Res Inst, POB 17969, Durham, NC 27715 USA
Curtis, Lesley H.
Peterson, Eric D.
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机构:
Duke Clin Res Inst, POB 17969, Durham, NC 27715 USA
Duke Univ, Med Ctr, Dept Med, Div Cardiol, Durham, NC 27710 USADuke Clin Res Inst, POB 17969, Durham, NC 27715 USA