메뉴 건너뛰기




Volumn 17, Issue 2, 1998, Pages 63-83

Non-clinical safety studies for biotechnologically-derived pharmaceuticals: Conclusions from an international workshop

Author keywords

Biotechnology; Non clinical; Pharmaceutical; Safety evaluation

Indexed keywords

COLONY STIMULATING FACTOR; GROWTH FACTOR; HORMONE; INTERFERON; INTERLEUKIN DERIVATIVE; MONOCLONAL ANTIBODY;

EID: 0031907908     PISSN: 09603271     EISSN: None     Source Type: Journal    
DOI: 10.1191/096032798678908341     Document Type: Review
Times cited : (10)

References (22)
  • 1
    • 0345005728 scopus 로고
    • Non-clinical Safety Testing of Products of Biotechnology: Issues of Concern
    • CMR95-63R, December
    • Non-clinical Safety Testing of Products of Biotechnology: Issues of Concern. Griffiths SA, Ashton GA and Lumley CE. CMR International Report, CMR95-63R, December 1995.
    • (1995) CMR International Report
    • Griffiths, S.A.1    Ashton, G.A.2    Lumley, C.E.3
  • 4
    • 0026621068 scopus 로고
    • Progress and challenges in the preclinical assessment of cytokines
    • Hayes TJ, Cavagnaro JA. Progress and challenges in the preclinical assessment of cytokines. Toxicology Letters 1992; 64/65: 291-297.
    • (1992) Toxicology Letters , vol.64-65 , pp. 291-297
    • Hayes, T.J.1    Cavagnaro, J.A.2
  • 5
    • 0345229484 scopus 로고
    • Development of biological therapies for oncologic use
    • 2nd ed (eds) DeVita VT. Hellman S and Rosenberg SA, JB Lippincott Company
    • Siegel JP et al Development of biological therapies for oncologic use. In: Biologic Therapy of Cancer 1995; 2nd ed (eds) DeVita VT. Hellman S and Rosenberg SA, JB Lippincott Company, pp 879-890.
    • (1995) Biologic Therapy of Cancer , pp. 879-890
    • Siegel, J.P.1
  • 7
    • 0002868026 scopus 로고
    • Biologic therapy with interferon-alpha and beta: Preclinical studies
    • 2nd ed, (eds) Devita VT, Hellman S and Rosenberg SA, JB Lippincott Company
    • Sreevalasan T. Biologic therapy with interferon-alpha and beta: preclinical studies. In: Biologic Therapy of Cancer. 1995; 2nd ed, (eds) Devita VT, Hellman S and Rosenberg SA, JB Lippincott Company, pp 347-364.
    • (1995) Biologic Therapy of Cancer , pp. 347-364
    • Sreevalasan, T.1
  • 8
    • 0002582371 scopus 로고
    • Biology of cytokines: The interleukins
    • 2nd ed, (eds) DeVita VT, Hellman S and Rosenberg SA, JB Lippincott Company
    • Tushinski RJ, Mule JJ. Biology of cytokines: the interleukins. In: Biologic Therapy of Cancer. 1995; 2nd ed, (eds) DeVita VT, Hellman S and Rosenberg SA, JB Lippincott Company, pp 87-102.
    • (1995) Biologic Therapy of Cancer , pp. 87-102
    • Tushinski, R.J.1    Mule, J.J.2
  • 9
    • 0031127953 scopus 로고    scopus 로고
    • Safety considerations for recombinant protein therapy: Introductory comments
    • Hayes TJ, Ryffel B. Safety considerations for recombinant protein therapy: introductory comments. Clinical Immunology and Immunopathology 1997; 83: 1-4.
    • (1997) Clinical Immunology and Immunopathology , vol.83 , pp. 1-4
    • Hayes, T.J.1    Ryffel, B.2
  • 10
    • 0027344992 scopus 로고
    • Comparative toxicity and pathology associated with administration of recombinant HuIL-1 alpha to animals
    • Anderson TD, Arceco R, Hayes TJ. Comparative toxicity and pathology associated with administration of recombinant HuIL-1 alpha to animals. International Review of Experimental Pathology 1993; 34(A): 9-36.
    • (1993) International Review of Experimental Pathology , vol.34 , Issue.A , pp. 9-36
    • Anderson, T.D.1    Arceco, R.2    Hayes, T.J.3
  • 11
    • 0027345589 scopus 로고
    • Comparative toxicity and pathology associated with administration of recombinant IL-2 to animals
    • Anderson TD et al. Comparative toxicity and pathology associated with administration of recombinant IL-2 to animals. International Review of Experimental Pathology 1993; 34A: 57-77.
    • (1993) International Review of Experimental Pathology , vol.34 A , pp. 57-77
    • Anderson, T.D.1
  • 12
    • 0017192259 scopus 로고
    • Depression of hepatic cytochrome P-450 dependent monooxygenase systems with administered interferon inducing agents
    • Renton KW, Mannering GJ. Depression of hepatic cytochrome P-450 dependent monooxygenase systems with administered interferon inducing agents. Biochemical and Biophysical Research Communications 1976; 73: 343-348.
    • (1976) Biochemical and Biophysical Research Communications , vol.73 , pp. 343-348
    • Renton, K.W.1    Mannering, G.J.2
  • 13
    • 0020454831 scopus 로고
    • Effects of three recombinant human leukocyte interferons on drug metabolism in mice
    • Parkinson A et al. Effects of three recombinant human leukocyte interferons on drug metabolism in mice. Drug Metabolism and Disposition 1982; 10 579-585.
    • (1982) Drug Metabolism and Disposition , vol.10 , pp. 579-585
    • Parkinson, A.1
  • 15
    • 0028013446 scopus 로고
    • Regulation of cytochrome P-450A and cytochrome P-4502E induction in the rat during the production of interferon alpha/beta
    • Cribb AE et al. Regulation of cytochrome P-450A and cytochrome P-4502E induction in the rat during the production of interferon alpha/beta. Journal of Pharmacology and Experimental Therapeutics 1994; 268: 487-494.
    • (1994) Journal of Pharmacology and Experimental Therapeutics , vol.268 , pp. 487-494
    • Cribb, A.E.1
  • 16
    • 0029022894 scopus 로고
    • The duration of induction and species influences the downregulation of cytochrome P450 by the interferon inducer polyinosinic acid-polycytidylic acid
    • Anari MR, Cribb AE, Renton KW. The duration of induction and species influences the downregulation of cytochrome P450 by the interferon inducer polyinosinic acid-polycytidylic acid. Drug Metabolism and Disposition 1995; 23: 536-541.
    • (1995) Drug Metabolism and Disposition , vol.23 , pp. 536-541
    • Anari, M.R.1    Cribb, A.E.2    Renton, K.W.3
  • 17
    • 0022632301 scopus 로고
    • The preclinical development of Roferon-A
    • Trown PW, Wills RJ, Kamm JJ. The preclinical development of Roferon-A. Cancer 1986; 57: 1648-1656.
    • (1986) Cancer , vol.57 , pp. 1648-1656
    • Trown, P.W.1    Wills, R.J.2    Kamm, J.J.3
  • 18
    • 0027354350 scopus 로고
    • Comparative pathology of recombinant murine interferon-gamma in mice and recombinant human interferon-gamma in cynomologous monkeys
    • Terrel J, Green JD. Comparative pathology of recombinant murine interferon-gamma in mice and recombinant human interferon-gamma in cynomologous monkeys. International Review of Experimental Pathology 1993; 34B: 73-101.
    • (1993) International Review of Experimental Pathology , vol.34 B , pp. 73-101
    • Terrel, J.1    Green, J.D.2
  • 19
    • 0031127020 scopus 로고    scopus 로고
    • Interleukin-12: Role of interferon-gamma in IL-12 adverse effects
    • Ryffel B. Interleukin-12: role of interferon-gamma in IL-12 adverse effects. Clinical Immunology and Immunopathology 1997; 83: 18-20.
    • (1997) Clinical Immunology and Immunopathology , vol.83 , pp. 18-20
    • Ryffel, B.1
  • 20
    • 0029062597 scopus 로고
    • IL-12 at the crossroads [news]
    • Hall SS. IL-12 at the crossroads [news]. Science 1995; 268: 1432-1434.
    • (1995) Science , vol.268 , pp. 1432-1434
    • Hall, S.S.1
  • 22
    • 6844222108 scopus 로고    scopus 로고
    • Designing non-clinical safety evaluation programmes: The view of the clinician
    • (Eds) Griffiths SA and Lumley CE. Kluwer Academic Publishers: The Netherlands. ISBN 0-7923-8732-5
    • Lipani J. Designing non-clinical safety evaluation programmes: The view of the clinician. In: Safety Evaluation of Biotechnologically-derived pharmaceuticals: Facilitating a Scientific Approach. (Eds) Griffiths SA and Lumley CE. Kluwer Academic Publishers: The Netherlands. 1997. ISBN 0-7923-8732-5.
    • (1997) Safety Evaluation of Biotechnologically-derived Pharmaceuticals: Facilitating a Scientific Approach
    • Lipani, J.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.