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Journal Abstract Search

480 related items for PubMed ID: 15645667

  • 1. European Regulatory guidance on virus safety of recombinant proteins, monoclonal antibodies and plasma derived medicinal products.
    Celis P, Silvester G.
    Dev Biol (Basel); 2004; 118():3-10. PubMed ID: 15645667
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  • 4. An industry perspective on plasma-derived products.
    von Hoegen I.
    Dev Biol (Basel); 2004; 118():31-5. PubMed ID: 15645670
    [No Abstract] [Full Text] [Related]

  • 5. EEC regulatory document. Note for guidance. Validation of virus removal and inactivation procedures. Committee for Proprietary Medicinal Products: Ad Hoc Working Party on Biotechnology/Pharmacy and Working Party on Safety Medicines.
    Biologicals; 1991 Jul; 19(3):247-51. PubMed ID: 1954007
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  • 7. European project concerning the guidelines on medicinal products derived from human blood and plasma.
    Horaud F.
    Dev Biol Stand; 1991 Jul; 75():237-40. PubMed ID: 1794627
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  • 8. Note for guidance. Production and quality control of human monoclonal antibodies. Committee for Proprietary Medicinal Products: Ad hoc Working Party on Biotechnology/Pharmacy and Working Party on Safety Medicines.
    Biologicals; 1991 Apr; 19(2):133-8. PubMed ID: 1888492
    [No Abstract] [Full Text] [Related]

  • 9. The quality control of biotechnology products.
    Federici MM.
    Biologicals; 1994 Jun; 22(2):151-9. PubMed ID: 7917231
    [No Abstract] [Full Text] [Related]

  • 10. Validation of removal of human retroviruses.
    Marcus-Sekura CJ.
    Dev Biol Stand; 1991 Jun; 75():133-43. PubMed ID: 1794615
    [Abstract] [Full Text] [Related]

  • 11. 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]

  • 12. Well-characterized biotechnology products: evolving to meet the needs of the 21st century.
    Zoon KC.
    Dev Biol Stand; 1998 Sep 24; 96():3-8. PubMed ID: 9890510
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  • 13. Definition of a well-characterized biotechnology product.
    Zoon K, Garnick R.
    Dev Biol Stand; 1998 Sep 24; 96():191-7. PubMed ID: 9890531
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  • 14. Process scale considerations in evaluation studies and scale-up.
    Walter JK, Werz W, Berthold W.
    Dev Biol Stand; 1996 Sep 24; 88():99-108. PubMed ID: 9119169
    [Abstract] [Full Text] [Related]

  • 15. Validation of virus removal in large scale purification processes.
    Fritsch E.
    Dev Biol Stand; 1992 Sep 24; 76():239-48. PubMed ID: 1478342
    [No Abstract] [Full Text] [Related]

  • 16. The procedure for marketing authorization for veterinary medicinal products derived from biotechnology in the European community.
    Brunko P.
    Dev Biol Stand; 1992 Sep 24; 79():11-5. PubMed ID: 1286745
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  • 17. Protein purification: aspects of processes for pharmaceutical products.
    Berthold W, Walter J.
    Biologicals; 1994 Jun 24; 22(2):135-50. PubMed ID: 7917230
    [Abstract] [Full Text] [Related]

  • 18. Note for guidance. Guidelines for medicinal products derived from human blood and plasma. Committee for Proprietary Medicinal Products: Ad Hoc Working Party on Biotechnology/Pharmacy and Working Party on Safety Medicines.
    Biologicals; 1992 Jun 24; 20(2):159-64. PubMed ID: 1389112
    [No Abstract] [Full Text] [Related]

  • 19. 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 Jun 24; 93():177-201. PubMed ID: 9737396
    [No Abstract] [Full Text] [Related]

  • 20. Virological issues in the use of cell therapies.
    Minor PD.
    Dev Biol (Basel); 2004 Jun 24; 118():151-3. PubMed ID: 15645685
    [Abstract] [Full Text] [Related]

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