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Journal Abstract Search

200 related items for PubMed ID: 16330220

  • 21. Consideration on a few aspects of the stability studies post licensure.
    Pierard I, Spelte G, Le Tallec D, Duchêne M.
    Biologicals; 2009 Nov; 37(6):403-6; discussion 421-3. PubMed ID: 19853472
    [Abstract] [Full Text] [Related]

  • 22. Current issues in viral assays and viral clearance evaluation.
    Lubiniecki AS.
    Dev Biol Stand; 1996 Nov; 88():9-11. PubMed ID: 9119167
    [Abstract] [Full Text] [Related]

  • 23. Protein purification: aspects of processes for pharmaceutical products.
    Berthold W, Walter J.
    Biologicals; 1994 Jun; 22(2):135-50. PubMed ID: 7917230
    [Abstract] [Full Text] [Related]

  • 24. Demonstration of robust host cell protein clearance in biopharmaceutical downstream processes.
    Shukla AA, Jiang C, Ma J, Rubacha M, Flansburg L, Lee SS.
    Biotechnol Prog; 2008 Jun; 24(3):615-22. PubMed ID: 18410156
    [Abstract] [Full Text] [Related]

  • 25. The scope and requirements related to preclinical and clinical studies of a new medicinal product, including biotechnological and biosimilar products.
    Brodniewicz-Proba T.
    Acta Pol Pharm; 2008 Jun; 65(6):641-5. PubMed ID: 19172845
    [Abstract] [Full Text] [Related]

  • 26. Identification of tobramycin impurities for quality control process monitoring using high-performance anion-exchange chromatography with integrated pulsed amperometric detection.
    Hanko VP, Rohrer JS, Liu HH, Zheng C, Zhang S, Liu X, Tang X.
    J Pharm Biomed Anal; 2008 Aug 05; 47(4-5):828-33. PubMed ID: 18486398
    [Abstract] [Full Text] [Related]

  • 27. Manufacturing considerations for clinical uses of therapies derived from stem cells.
    Weber DJ.
    Methods Enzymol; 2006 Aug 05; 420():410-30. PubMed ID: 17161709
    [Abstract] [Full Text] [Related]

  • 28. Immunogenicity of biopharmaceuticals.
    Kessler M, Goldsmith D, Schellekens H.
    Nephrol Dial Transplant; 2006 Oct 05; 21 Suppl 5():v9-12. PubMed ID: 16959792
    [Abstract] [Full Text] [Related]

  • 29. Criteria for investigation of the product equivalence of monoclonal antibodies for therapeutic and in vivo-diagnostic use in case of introduction of changes in the manufacturing process.
    Schäffner G, Haase M, Giess S.
    Biologicals; 1995 Sep 05; 23(3):253-9. PubMed ID: 8527127
    [Abstract] [Full Text] [Related]

  • 30. 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 Sep 05; 93():211-9. PubMed ID: 9737398
    [No Abstract] [Full Text] [Related]

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  • 32. Viral safety and clearance evaluation--implications for process change and comparability.
    Dinowitz M.
    Dev Biol (Basel); 2002 Sep 05; 109():121-6. PubMed ID: 12434921
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  • 34. Viral validation design of a manufacturing process.
    Larzul D.
    Dev Biol Stand; 1999 Sep 05; 99():139-50. PubMed ID: 10404885
    [Abstract] [Full Text] [Related]

  • 35. Regulatory expectation for data on viral testing and process evaluation for phase I studies and product licensing in the United States, Europe and Japan.
    Koga J.
    Dev Biol Stand; 1996 Sep 05; 88():152-3. PubMed ID: 9119130
    [No Abstract] [Full Text] [Related]

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  • 37. A regulatory perspective on issues and approaches in characterizing human metabolites.
    Davis-Bruno KL, Atrakchi A.
    Chem Res Toxicol; 2006 Dec 05; 19(12):1561-3. PubMed ID: 17173368
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