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PUBMED FOR HANDHELDS

Journal Abstract Search


347 related items for PubMed ID: 9737396

  • 1. Quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. ICH Harmonised Tripartite Guideline.
    Dev Biol Stand; 1998; 93():177-201. PubMed ID: 9737396
    [No Abstract] [Full Text] [Related]

  • 2. Quality of biotechnological products: analysis of the expression construct in cell lines used for production of r-DNA derived protein products. ICH Harmonised Tripartite Guideline.
    Dev Biol Stand; 1998; 93():205-8. PubMed ID: 9737397
    [No Abstract] [Full Text] [Related]

  • 3. Quality of biotechnological products: derivation and characterisation of cell substrates used for production of biotechnological/biological products. ICH Harmonised Tripartite Guideline.
    Dev Biol Stand; 1998; 93():223-34. PubMed ID: 9737399
    [No Abstract] [Full Text] [Related]

  • 4. Quality of biotechnological products: stability testing of biotechnological/biological products. Annex to the ICH Harmonised Tripartite Guideline for the Stability Testing of New Drug Substances and Products.
    Dev Biol Stand; 1998; 93():211-9. PubMed ID: 9737398
    [No Abstract] [Full Text] [Related]

  • 5. International Conference on Harmonisation; guidance on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin; availability--FDA. Notice.
    Fed Regist; 1998 Sep 24; 63(185):51074-84. PubMed ID: 10185809
    [Abstract] [Full Text] [Related]

  • 6. WHO requirements for the use of animal cells as in vitro substrates for the production of biologicals (requirements for biological substances No 50).
    Dev Biol Stand; 1998 Sep 24; 93():141-71. PubMed ID: 9737395
    [No Abstract] [Full Text] [Related]

  • 7. Safety of biological products prepared from mammalian cell culture. In-process testing for viral agents.
    Dev Biol Stand; 1998 Sep 24; 93():130-1. PubMed ID: 9737389
    [No Abstract] [Full Text] [Related]

  • 8. Issues related to harmonization of testing requirements for viral safety.
    Hayakawa T.
    Dev Biol Stand; 1996 Sep 24; 88():15-8. PubMed ID: 9119129
    [Abstract] [Full Text] [Related]

  • 9. Safety of biological products prepared from mammalian cell culture. Detecting viruses in cell banks.
    Dev Biol Stand; 1998 Sep 24; 93():129. PubMed ID: 9737388
    [No Abstract] [Full Text] [Related]

  • 10. International Conference on Harmonisation; guidance on quality of biotechnological/biological products: derivation and characterization of cell substrates used for production of biotechnological/biological products; availability. Notice. Food and Drug Administration, HHS.
    Fed Regist; 1998 Sep 21; 63(182):50244-9. PubMed ID: 12269373
    [Abstract] [Full Text] [Related]

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  • 13. Survey of manufacturers and developers of cell culture-derived products for evidence of adventitious contamination.
    Lubiniecki AS.
    Dev Biol Stand; 1996 Sep 21; 88():195-7. PubMed ID: 9119136
    [No Abstract] [Full Text] [Related]

  • 14. Safety issues of animal products used in serum-free media.
    Merten OW.
    Dev Biol Stand; 1999 Sep 21; 99():167-80. PubMed ID: 10404888
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  • 17. European Regulatory guidance on virus safety of recombinant proteins, monoclonal antibodies and plasma derived medicinal products.
    Celis P, Silvester G.
    Dev Biol (Basel); 2004 Sep 21; 118():3-10. PubMed ID: 15645667
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  • 19. ICH guidelines and PhEur monographs on derivation and characterisation of cell substrates used for production of biotechnological/biological products. International Conference on Harmonisation.
    Dobbelaer R.
    Dev Biol Stand; 1999 Sep 21; 98():159-65; discussion 167. PubMed ID: 10494969
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