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Volumn , Issue , 2007, Pages 337-341

Genetic Toxicology Testing of Biopharmaceuticals

Author keywords

Biopharmaceutical genetic toxicology testing; Genetic toxicity decision tree and biopharmaceuticals; Genotoxicity assay 44 FDA approved biopharmaceuticals

Indexed keywords


EID: 77955294254     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470292549.ch15     Document Type: Chapter
Times cited : (6)

References (8)
  • 2
    • 0023029849 scopus 로고
    • The restriction endonuclease Alu I induces chromosomal aberrations in human peripheral blood lymphocytes in vitro
    • Obe G , Jonas R , Schmidt S. The restriction endonuclease Alu I induces chromosomal aberrations in human peripheral blood lymphocytes in vitro . Mutat Res 1986 ; 163: 271 - 5 .
    • (1986) Mutat Res , vol.163 , pp. 271-275
    • Obe, G.1    Jonas, R.2    Schmidt, S.3
  • 3
    • 0023699795 scopus 로고
    • Evidence for a recptor - mediated endocytosis of Alu I in Chinese hamster ovary cells
    • Vasudev V , Obe G. Evidence for a recptor - mediated endocytosis of Alu I in Chinese hamster ovary cells . Mutat Res 1988 ; 197: 109 - 16 .
    • (1988) Mutat Res , vol.197
    • Vasudev, V.1    Obe, G.2
  • 4
    • 0033093819 scopus 로고    scopus 로고
    • Genotoxicity testing of biotechnology - derived products. Report of a GUM task force
    • Gocke E , Albertini S , Brendel - Schwaab S , Muller L , Suter W , et al. Genotoxicity testing of biotechnology - derived products. Report of a GUM task force . Mutat Res 1999 ; 436: 137 - 56 .
    • (1999) Mutat Res , vol.436 , pp. 137-156
    • Gocke, E.1    Albertini, S.2    Brendel-Schwaab, S.3    Muller, L.4    Suter, W.5
  • 5
    • 84891535193 scopus 로고    scopus 로고
    • FDA Draft Guidance for Industry, Nonclinical Safety Evaluation of Biotechnology - Derived Pharmaceuticals (in preparation)
    • FDA Draft Guidance for Industry, Nonclinical Safety Evaluation of Biotechnology - Derived Pharmaceuticals (in preparation).
  • 6
    • 0027175572 scopus 로고
    • Genotoxicty of genetic recombinant erythropoietin in a novel test system
    • Yajima N , Kurata Y , Imai E , Sawai T , Takeshita Y. Genotoxicty of genetic recombinant erythropoietin in a novel test system . Mutagenesis 1993 ; 8: 231 - 6 .
    • (1993) Mutagenesis , vol.8
    • Yajima, N.1    Kurata, Y.2    Imai, E.3    Sawai, T.4    Takeshita, Y.5
  • 7
    • 0027175574 scopus 로고    scopus 로고
    • Comparative studies in induction of micronuclei by three genetically recombinant and urinary human erythropoietins
    • Yajima N , Kurata Y , Sawai T , Takeshita Y. Comparative studies in induction of micronuclei by three genetically recombinant and urinary human erythropoietins . Mutagenesis 2003 ; 8: 237 - 41 .
    • (2003) Mutagenesis , vol.8 , pp. 237-241
    • Yajima, N.1    Kurata, Y.2    Sawai, T.3    Takeshita, Y.4
  • 8
    • 0027215247 scopus 로고    scopus 로고
    • Induction of micronucleated erythrocytes by recombinant human erythropoietin
    • Yajima N , Kurata Y , Sawai T , Takeshita Y. Induction of micronucleated erythrocytes by recombinant human erythropoietin . Mutagenesis 2003 ; 8: 221 - 9 .
    • (2003) Mutagenesis , vol.8 , pp. 221-229
    • Yajima, N.1    Kurata, Y.2    Sawai, T.3    Takeshita, Y.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.