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Journal Abstract Search

365 related items for PubMed ID: 16375258

  • 1. Characterization of gene therapy products and the impact of manufacturing changes on product comparability.
    Simek SL.
    Dev Biol (Basel); 2005; 122():139-44. PubMed ID: 16375258
    [Abstract] [Full Text] [Related]

  • 2. Characterizing biological products and assessing comparability following manufacturing changes.
    Chirino AJ, Mire-Sluis A.
    Nat Biotechnol; 2004 Nov; 22(11):1383-91. PubMed ID: 15529163
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  • 5. Process and product development in the manufacturing of molecular therapeutics.
    Atkinson EM, Christensen JR.
    Curr Opin Mol Ther; 1999 Aug; 1(4):422-9. PubMed ID: 11713755
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  • 6. Regulatory philosophy for comparability protocols.
    Moos M.
    Dev Biol (Basel); 2002 Aug; 109():53-6. PubMed ID: 12434913
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  • 7. Biological products: reporting of biological product deviations in manufacturing. Food and Drug Administration, HHS. Final rule.
    Fed Regist; 2000 Nov 07; 65(216):66621-35. PubMed ID: 11503696
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  • 8. 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
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  • 9. Regulatory perspectives from Japan - comparability of biopharmaceuticals.
    Kawanishi T.
    Biologicals; 2006 Mar 01; 34(1):65-8. PubMed ID: 16330220
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  • 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
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  • 15. Preparing for an FDA preapproval inspection.
    Blackmer RA.
    Qual Assur; 1994 Dec 01; 3(4):389-403. PubMed ID: 7613749
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  • 16. Supplements and other changes to an approved application. Final rule.
    Food and Drug Administration, HHS.
    Fed Regist; 2004 Apr 08; 69(68):18727-67. PubMed ID: 15072041
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  • 18. Recommendations regarding technical standards for follow-on biologics: comparability, similarity, interchangeability.
    Davis GC, Beals JM, Johnson C, Mayer MH, Meiklejohn BI, Mitlak BH, Roth JL, Towns JK, Veenhuizen M.
    Curr Med Res Opin; 2009 Jul 08; 25(7):1655-61. PubMed ID: 19476407
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  • 19. The challenge of follow-on biologics for treatment of multiple sclerosis.
    Reingold SC, Steiner JP, Polman CH, Cohen JA, Freedman MS, Kappos L, Thompson AJ, Wolinsky JS.
    Neurology; 2009 Aug 18; 73(7):552-9. PubMed ID: 19687456
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  • 20. Development and approval of vaccines in the United States.
    Botstein P.
    Isr J Med Sci; 1986 Aug 18; 22(3-4):268-71. PubMed ID: 3528047
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