메뉴 건너뛰기




Volumn 8, Issue 3, 1997, Pages 350-356

Potential influence of international harmonization of pharmaceutical regulations on biopharmaceutical development

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

EID: 0030962084     PISSN: 09581669     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0958-1669(97)80016-X     Document Type: Article
Times cited : (8)

References (30)
  • 1
    • 0007097059 scopus 로고    scopus 로고
    • Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
    • International Conference on Harmonization, Expert Working Group on Biotechnology Quality. Quality of Biotechnological Products: stability Testing of Biotechnological/Biological Products. Fed Reg 1998 61:36466-36469.
    • (1998) Fed Reg , vol.61 , pp. 36466-36469
  • 2
    • 0001682064 scopus 로고    scopus 로고
    • Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of rONA Derived Protein Products
    • International Conference on Harmonization, Expert Working Group on Biotechnology Quality. Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of rONA Derived Protein Products. Fed Reg 1996, 61:7006-7008.
    • (1996) Fed Reg , vol.61 , pp. 7006-7008
  • 3
    • 0028718324 scopus 로고
    • Genetic stability of rDNa production systems, a case report
    • Chiu YY: Genetic stability of rDNA production systems, a case report. Dev Biol Standard 1994, 83:93-97.
    • (1994) Dev Biol Standard , vol.83 , pp. 93-97
    • Chiu, Y.Y.1
  • 4
    • 0011374901 scopus 로고
    • Assessment of genetic stability of biotechnology products
    • Committee on Process Development and Manufacturing, Pharmaceutical Manufacturers Association: Assessment of genetic stability of biotechnology products. Bio/Pharm 1991, 4:22-27.
    • (1991) Bio/Pharm , vol.4 , pp. 22-27
  • 5
    • 0028709504 scopus 로고
    • Report on the genetic stability symposium West Coast chapter, parenteral drug association
    • Garnick R, Helder JC: Report on the genetic stability symposium West Coast chapter, parenteral drug association. Dev Biol Standard 1994, 83:177-178.
    • (1994) Dev Biol Standard , vol.83 , pp. 177-178
    • Garnick, R.1    Helder, J.C.2
  • 6
    • 85030293057 scopus 로고    scopus 로고
    • Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drugs and Biologics, Office of Biologic Research and Review: Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology. Rockville: FDA: 1985.
    • Rockville: FDA , pp. 1985
  • 8
    • 0025153689 scopus 로고
    • Stability of a gene recombinant: What does it mean and how to check for it?
    • Galibert F: Stability of a gene recombinant: what does it mean and how to check for it? Biologicals 1990, 18:221-224.
    • (1990) Biologicals , vol.18 , pp. 221-224
    • Galibert, F.1
  • 9
    • 0025647359 scopus 로고
    • Letter to the editor
    • Galibert F: Letter to the editor. Biologicals 1990, 18:355.
    • (1990) Biologicals , vol.18 , pp. 355
    • Galibert, F.1
  • 13
    • 0028718081 scopus 로고
    • Translational errors during recombinant protein synthesis
    • Rosenberger R: Translational errors during recombinant protein synthesis. Dev Biol Standard 1994, 83:21-26.
    • (1994) Dev Biol Standard , vol.83 , pp. 21-26
    • Rosenberger, R.1
  • 14
    • 0028691996 scopus 로고
    • Peptide mapping of recombinant proteins
    • Rohde M, Lu H, Rush R: Peptide mapping of recombinant proteins. Dev Biol Standard 1994, 83:121-127.
    • (1994) Dev Biol Standard , vol.83 , pp. 121-127
    • Rohde, M.1    Lu, H.2    Rush, R.3
  • 17
    • 0343119117 scopus 로고    scopus 로고
    • Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
    • International Conference of Harmonization, Expert Working Group on Biotechnology Quality: Draft Guideline on Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. Fed Reg 1996, 61:21882-21891.
    • (1996) Fed Reg , vol.61 , pp. 21882-21891
  • 18
    • 0020479843 scopus 로고
    • Possible transfusion-associated acquired immunodeficiency syndrome (AIDS)-California
    • Centers for Disease Control: Possible transfusion-associated acquired immunodeficiency syndrome (AIDS)-California. Morbid Mortal Weekly Rep 1982, 31:652-654.
    • (1982) Morbid Mortal Weekly Rep , vol.31 , pp. 652-654
  • 19
    • 0022423092 scopus 로고
    • Provisional Public Health Service inter-agency recommendations for screening donated blood and plasma for antibody to the virus causing acquired immunodeficiency syndrome
    • Centers for Disease Control: Provisional Public Health Service inter-agency recommendations for screening donated blood and plasma for antibody to the virus causing acquired immunodeficiency syndrome. Morbid Mortal Weekly Rep 1985, 34:1-5.
    • (1985) Morbid Mortal Weekly Rep , vol.34 , pp. 1-5
  • 21
    • 0027791870 scopus 로고
    • Inactivation of HIV, HBV, HCV, HCV related viruses and other viruses in human plasma derivatives by pasteurization
    • Nowak T, Niedrig M, Bernhardt D, Hilfenhaus J: Inactivation of HIV, HBV, HCV, HCV related viruses and other viruses in human plasma derivatives by pasteurization. Dev Biol Standard 1993, 81:169-176.
    • (1993) Dev Biol Standard , vol.81 , pp. 169-176
    • Nowak, T.1    Niedrig, M.2    Bernhardt, D.3    Hilfenhaus, J.4
  • 22
    • 84956690235 scopus 로고
    • February 1991. Brussels: European Commission; [III/8115/89-EN Final]
    • Commission of the European Communities: Validation of Virus Removal and Inactivation Procedures. February 1991. Brussels: European Commission; 1991. [III/8115/89-EN Final].
    • (1991) Validation of Virus Removal and Inactivation Procedures
  • 23
    • 0343119115 scopus 로고
    • December 1991. Brussels: European Commission; [III/8379/89-EN Final]
    • Commission of the European Communities: Medicinal Products Derived from Human Blood and Plasma. December 1991. Brussels: European Commission; 1991 [III/8379/89-EN Final.]
    • (1991) Medicinal Products Derived from Human Blood and Plasma
  • 24
    • 0030340778 scopus 로고    scopus 로고
    • Contamination of genetically engineered Chinese hamster ovary cells
    • Burstyn D: Contamination of genetically engineered Chinese hamster ovary cells. Dev Biol Standard 1996, 88:199-203.
    • (1996) Dev Biol Standard , vol.88 , pp. 199-203
    • Burstyn, D.1
  • 25
    • 0019190161 scopus 로고
    • The association of calf serum with the contamination of BHK21 suspension cells by a parvovirus serologically related to Minute Virus of Mice (MVM)
    • Nettleton P, Rweyemamu M: The association of calf serum with the contamination of BHK21 suspension cells by a parvovirus serologically related to Minute Virus of Mice (MVM). Arch Virol 1980, 64:359-374.
    • (1980) Arch Virol , vol.64 , pp. 359-374
    • Nettleton, P.1    Rweyemamu, M.2
  • 26
    • 0030334226 scopus 로고    scopus 로고
    • Experience with viral contamination in cell culture
    • Garnick R: Experience with viral contamination in cell culture. Dev Biol Standard 1996, 88:49-56.
    • (1996) Dev Biol Standard , vol.88 , pp. 49-56
    • Garnick, R.1
  • 27
    • 0030342094 scopus 로고    scopus 로고
    • Survey of manufacturers and developers of cell culture-derived products for evidence of adventitious contamination
    • Lubiniecki A: Survey of manufacturers and developers of cell culture-derived products for evidence of adventitious contamination. Dev Biol Standard 1996, 88:195-197.
    • (1996) Dev Biol Standard , vol.88 , pp. 195-197
    • Lubiniecki, A.1
  • 28
    • 85030294389 scopus 로고    scopus 로고
    • Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products
    • January Geneva
    • International Conference on Harmonization Expert Working Group on Biotechnology Quality. Quality of Biotechnological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products. January 1997. International Conference on Harmonization, Geneva.
    • (1997) International Conference on Harmonization
  • 30
    • 85030293200 scopus 로고    scopus 로고
    • Preclinical Testing of Biotechnology-Dervied Pharmaceuticals
    • November Geneva
    • International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use: Preclinical Testing of Biotechnology-Dervied Pharmaceuticals. November 1996. International Conference on Harmonization, Geneva.
    • (1996) International Conference on Harmonization


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.