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Journal Abstract Search

200 related items for PubMed ID: 16330220

  • 1.
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  • 2. International Conference on Harmonisation; guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process; availability. Notice.
    Food and Drug Administration, HHS.
    Fed Regist; 2005 Jun 30; 70(125):37861-2. PubMed ID: 15988855
    [Abstract] [Full Text] [Related]

  • 3. The role of formulation in insulin comparability assessments.
    Defelippis MR, Larimore FS.
    Biologicals; 2006 Mar 30; 34(1):49-54. PubMed ID: 16330222
    [Abstract] [Full Text] [Related]

  • 4. Characterization of gene therapy products and the impact of manufacturing changes on product comparability.
    Simek SL.
    Dev Biol (Basel); 2005 Mar 30; 122():139-44. PubMed ID: 16375258
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  • 7. Changes in biological source material.
    Robertson JS.
    Biologicals; 2006 Mar 30; 34(1):61-3. PubMed ID: 16330224
    [Abstract] [Full Text] [Related]

  • 8. Manufacturing, regulatory and commercial challenges of biopharmaceuticals production: a Finnish perspective.
    Närhi M, Nordström K.
    Eur J Pharm Biopharm; 2005 Apr 30; 59(3):397-405. PubMed ID: 15760720
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  • 10. A global view of comparability concepts.
    Petricciani J.
    Dev Biol (Basel); 2002 Apr 30; 109():9-13. PubMed ID: 12434908
    [Abstract] [Full Text] [Related]

  • 11. Microarray-based gene expression analysis as a process characterization tool to establish comparability of complex biological products: scale-up of a whole-cell immunotherapy product.
    Wang M, Senger RS, Paredes C, Banik GG, Lin A, Papoutsakis ET.
    Biotechnol Bioeng; 2009 Nov 01; 104(4):796-808. PubMed ID: 19591186
    [Abstract] [Full Text] [Related]

  • 12. The control of biological medicinal products produced by recombinant DNA technology.
    Griffiths E.
    Dev Biol Stand; 1985 Nov 01; 59():155-9. PubMed ID: 4007273
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  • 14. A biosimilar industry view on the implementation of the WHO guidelines on evaluating similar biotherapeutic products.
    Schiestl M.
    Biologicals; 2011 Sep 01; 39(5):297-9. PubMed ID: 21784654
    [Abstract] [Full Text] [Related]

  • 15. Process changes and their effect on process evaluation for viral clearance.
    Marcus-Sekura C.
    Dev Biol Stand; 1996 Sep 01; 88():125-30. PubMed ID: 9119123
    [Abstract] [Full Text] [Related]

  • 16. Regulatory guideline for biosimilar products in Korea.
    Suh SK, Park Y.
    Biologicals; 2011 Sep 01; 39(5):336-8. PubMed ID: 21784653
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  • 17. Product development of probiotics as biological drugs.
    Sutton A.
    Clin Infect Dis; 2008 Feb 01; 46 Suppl 2():S128-32; discussion S144-51. PubMed ID: 18181718
    [Abstract] [Full Text] [Related]

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