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Volumn 43, Issue 5, 2015, Pages 425-428

Preclinical safety testing for cell-based products using animals

Author keywords

Advanced therapy medicinal products; Cell therapy; Clinical trials; Marketing authorisation; Preclinical testing; Tumourigenicity

Indexed keywords

ABSORPTION; BIOLOGICAL MONITORING; BIOSAFETY; CARCINOGENICITY; CELL IMMORTALIZATION; CELL PROLIFERATION; CELL THERAPY; CELLULAR DISTRIBUTION; CHEMICAL REACTION KINETICS; CONFERENCE PAPER; ELIMINATION REACTION; GENOTOXICITY; HUMAN; IMMUNOCOMPETENCE; IN VITRO STUDY; IN VIVO STUDY; MUTAGENICITY; NONHUMAN; PRIORITY JOURNAL; RISK ASSESSMENT; ADVERSE EFFECTS; ANIMAL; BIOLOGICAL THERAPY; PATIENT SAFETY;

EID: 84941314426     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2015.05.002     Document Type: Conference Paper
Times cited : (5)

References (8)
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  • 2
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  • 3
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    • note for guidance on safety pharmacology studies for human pharmaceuticals CHMP/ICH/539/00.
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  • 4
    • 77950475517 scopus 로고    scopus 로고
    • Case report of a serious adverse event following the administration of T cells transduced with a chimeric antigen receptor recognizing ERBB2
    • Morgan R.A., Yang J.C., Kitano M., Dudley M.E., Laurencot C.M., Rosenberg S.A. Case report of a serious adverse event following the administration of T cells transduced with a chimeric antigen receptor recognizing ERBB2. Mol Ther 2010, 18(4):843-851.
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    • Morgan, R.A.1    Yang, J.C.2    Kitano, M.3    Dudley, M.E.4    Laurencot, C.M.5    Rosenberg, S.A.6
  • 5
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    • Cardiovascular toxicity and titin cross-reactivity of affinity-enhanced T cells in myeloma and melanoma
    • Linette G.P., Stadtmauer E.A., Maus M.V., Rapoport A.P., Levine B.L., Emery L., et al. Cardiovascular toxicity and titin cross-reactivity of affinity-enhanced T cells in myeloma and melanoma. Blood 2013, 122(6):863-871.
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    • Linette, G.P.1    Stadtmauer, E.A.2    Maus, M.V.3    Rapoport, A.P.4    Levine, B.L.5    Emery, L.6
  • 6
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    • Of mice, not men: no evidence for graft-versus-host disease in humans receiving T-cell receptor-transduced autologous T cells
    • Rosenberg S.A. Of mice, not men: no evidence for graft-versus-host disease in humans receiving T-cell receptor-transduced autologous T cells. Mol Ther 2010, 18(10):1744-1745.
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    • evaluation of cell substrates for the production of biological: revision of recommendations
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* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.