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Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials
Volumn , Issue , 2007, Pages 111-121
Implementation of ICH S6: US Perspective
Author keywords

Global strategies science driven and problem focused; ICH S6 giudance and specific considerations; ICH S6 implementation US perspective
Indexed keywords

EID: 84891534338     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470292549.ch6     Document Type: Chapter
Times cited : (5)
References (12)
  • 1
    • 0003796052 scopus 로고    scopus 로고
    • Preclinical Safety Evaluation of Biotechnology - Derived Pharmaceuticals
    • ICH S61 July
    • ICH S61. Preclinical Safety Evaluation of Biotechnology - Derived Pharmaceuticals. July 1997 .
    • (1997)
  • 2
    • 33748750980 scopus 로고    scopus 로고
    • Regulating biopharmaceuticals under CDER versus CBER: An Insider ' s perspective
    • Schwieterman WD . Regulating biopharmaceuticals under CDER versus CBER: An Insider ' s perspective . Drug Discov Today 2006 ; 11: 19 - 20 .
    • (2006) Drug Discov Today , vol.11 , pp. 19-20
    • Schwieterman, W.D.1
  • 3
    • 0036593951 scopus 로고    scopus 로고
    • Preclinical safety evaluation of biotechnology - derived pharmaceuticals
    • Cavagnaro JA . Preclinical safety evaluation of biotechnology - derived pharmaceuticals . Nat Rev 2002 ; 1: 469 .
    • (2002) Nat Rev , vol.1 , pp. 469
    • Cavagnaro, J.A.1
  • 4
    • 0029583168 scopus 로고
    • Safety Evaluation of biological and biotechnology - derived medicines
    • Dayan AD . Safety Evaluation of biological and biotechnology - derived medicines . Toxicology 1995 ; 105: 59 .
    • (1995) Toxicology , vol.105 , pp. 59
    • Dayan, A.D.1
  • 5
    • 0004125932 scopus 로고    scopus 로고
    • Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use
    • FDA,CBER
    • FDA, CBER. Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use, 1997 .
    • (1997)
  • 6
    • 0003582181 scopus 로고    scopus 로고
    • Specifi cations: Test Procedures and Acceptance Criteria for Biotechnological/ Biological Products
    • ICH Q6B August
    • ICH Q6B. Specifi cations: Test Procedures and Acceptance Criteria for Biotechnological/ Biological Products, August 1999 .
    • (1999)
  • 7
    • 0033024643 scopus 로고    scopus 로고
    • Safety assessment of biotechnology - derived pharmaceuticals: ICH and beyond
    • Serabian MA , Pilaro AM . Safety assessment of biotechnology - derived pharmaceuticals: ICH and beyond . Toxicol Pathol 1999 ; 27: 2 .
    • (1999) Toxicol Pathol , vol.27 , pp. 2
    • Serabian, M.A.1    Pilaro, A.M.2
  • 8
    • 0033916950 scopus 로고    scopus 로고
    • Using an analogous monoclonal antibody to evaluate the reproductive and chronic toxicity potential for a humanized anti - TNF a monoclonal antibody
    • Treacy G . Using an analogous monoclonal antibody to evaluate the reproductive and chronic toxicity potential for a humanized anti - TNF a monoclonal antibody . Hum Exper Toxicol 2000 ; 19: 226 .
    • (2000) Hum Exper Toxicol , vol.19 , pp. 226
    • Treacy, G.1
  • 9
    • 33744950980 scopus 로고    scopus 로고
    • Scientifi c and regulatory considerations on the immunogenicity of biologics
    • Shankar G , Shores E , Wagner C , Mire - Sluis A . Scientifi c and regulatory considerations on the immunogenicity of biologics . TRENDS Biotech 2006 ; 24: 274 - 80 .
    • (2006) TRENDS Biotech , vol.24 , pp. 274-80
    • Shankar, G.1    Shores, E.2    Wagner, C.3    Mire-Sluis, A.4
  • 10
    • 0036890997 scopus 로고    scopus 로고
    • Immune responses to therapeutic proteins in humans - clinical signifi cance, assessment and prediction
    • Koren E , Zuckerman LA , Mire - Sluis AR . Immune responses to therapeutic proteins in humans - clinical signifi cance, assessment and prediction . Curr Pharmaceut Biotech 2002 ; 3: 349 .
    • (2002) Curr Pharmaceut Biotech , vol.3 , pp. 349
    • Koren, E.1    Zuckerman, L.A.2    Mire-Sluis, A.R.3
  • 11
    • 37349045360 scopus 로고    scopus 로고
    • Duration of chronic toxicity studies for biotechnology - derived pharmaceuticals: is 6 months still appropriate?
    • Clarke J , Hurst C , Martin P , et al. Duration of chronic toxicity studies for biotechnology - derived pharmaceuticals: is 6 months still appropriate? Regul Toxicol Pharmacol 2008 ; 50: 2 - 22 .
    • (2008) Regul Toxicol Pharmacol , vol.50 , pp. 2-22
    • Clarke, J.1    Hurst, C.2    Martin, P.3
  • 12
    • 0242429967 scopus 로고    scopus 로고
    • The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals
    • ICH S1A March
    • ICH S1A. The Need for Long - term Rodent Carcinogenicity Studies of Pharmaceuticals, March 1996 .
    • (1996)

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.