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Journal Abstract Search

591 related items for PubMed ID: 19333875

  • 1. Risk reduction in biotherapeutic products.
    Ill CR, Dehghani H.
    Curr Opin Drug Discov Devel; 2009 Mar; 12(2):296-304. PubMed ID: 19333875
    [Abstract] [Full Text] [Related]

  • 2. Process scale considerations in evaluation studies and scale-up.
    Walter JK, Werz W, Berthold W.
    Dev Biol Stand; 1996 Mar; 88():99-108. PubMed ID: 9119169
    [Abstract] [Full Text] [Related]

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

  • 4. Adventitious agents from animal-derived raw materials--a method of risk assessment.
    Foster LG.
    Dev Biol Stand; 1996 Mar; 88():283-90. PubMed ID: 9119152
    [Abstract] [Full Text] [Related]

  • 5. Biosafety and product release testing issues relevant to replication-competent oncolytic viruses.
    Wisher M.
    Cancer Gene Ther; 2002 Dec; 9(12):1056-61. PubMed ID: 12522444
    [Abstract] [Full Text] [Related]

  • 6. Risk management, cGMP, and the evolution of aseptic processing technology.
    Agalloco J, Akers J, Baseman H, Boeh R, Madsen R, Ostrove S, Pavell A.
    PDA J Pharm Sci Technol; 2009 Dec; 63(1):8-10. PubMed ID: 19455938
    [No Abstract] [Full Text] [Related]

  • 7. Evaluation of anti-viral filters.
    Hughes B, Bradburne A, Sheppard A, Young D.
    Dev Biol Stand; 1996 Dec; 88():91-8. PubMed ID: 9119168
    [Abstract] [Full Text] [Related]

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

  • 9. Viral safety in homoeopathic medicinal products.
    Schultz N, Franck-Karl G, Schilk J, Rose N.
    Pharmeur Bio Sci Notes; 2011 Jun; 2011(1):55-65. PubMed ID: 21619856
    [Abstract] [Full Text] [Related]

  • 10. Microbiological Control for Affinity Capture Chromatography Processing: An Industry Perspective.
    Murphy M, Bell BL, Moshi J, Grassi R, Forng RY, Salaman A, Jordi PW, Zaidi S, Goodnight M, Paul M, Keller A, Carpenter B, Hearty U, Willison-Parry D.
    PDA J Pharm Sci Technol; 2018 Jun; 72(2):213-221. PubMed ID: 29444992
    [Abstract] [Full Text] [Related]

  • 11. Organic solvents in the pharmaceutical industry.
    Grodowska K, Parczewski A.
    Acta Pol Pharm; 2010 Jun; 67(1):3-12. PubMed ID: 20210074
    [Abstract] [Full Text] [Related]

  • 12. Low levels of extraneous agents in vaccine starting materials.
    Rouby JC.
    Biologicals; 2010 May; 38(3):354-7. PubMed ID: 20347331
    [Abstract] [Full Text] [Related]

  • 13. Pathogen safety of manufacturing processes for biological products: special emphasis on KOGENATE Bayer.
    Lee DC, Miller JL, Petteway SR.
    Haemophilia; 2002 Mar; 8 Suppl 2():6-9. PubMed ID: 11966845
    [Abstract] [Full Text] [Related]

  • 14. Safety assurance for biologics manufactured in mammalian cell cultures: a multitiered strategy.
    Chen D.
    Adv Biochem Eng Biotechnol; 2014 Mar; 139():167-83. PubMed ID: 23719711
    [Abstract] [Full Text] [Related]

  • 15. Viral safety and clearance evaluation--implications for process change and comparability.
    Dinowitz M.
    Dev Biol (Basel); 2002 Mar; 109():121-6. PubMed ID: 12434921
    [Abstract] [Full Text] [Related]

  • 16. Tracing and control of raw materials sourcing for vaccine manufacturers.
    Faretra Peysson L.
    Biologicals; 2010 May; 38(3):352-3. PubMed ID: 20335052
    [Abstract] [Full Text] [Related]

  • 17. Biopharmaceutical Industry Approaches to Facility Segregation for Viral Safety: An Effort from the Consortium on Adventitious Agent Contamination in Biomanufacturing.
    Barone PW, Avgerinos S, Ballard R, Brussel A, Clark P, Dowd C, Gerentes L, Hart I, Keumurian FJ, Kindermann J, Leung JC, Ly N, Mink S, Minning S, Mullberg J, Murphy M, Nöske K, Parriott S, Shum B, Wiebe ME, Springs SL.
    PDA J Pharm Sci Technol; 2019 May; 73(2):191-203. PubMed ID: 30361281
    [Abstract] [Full Text] [Related]

  • 18. Equipment and analytical companies meeting continuous challenges. May 20-21, 2014 Continuous Manufacturing Symposium.
    Page T, Dubina H, Fillipi G, Guidat R, Patnaik S, Poechlauer P, Shering P, Guinn M, Mcdonnell P, Johnston C.
    J Pharm Sci; 2015 Mar; 104(3):821-31. PubMed ID: 25448273
    [Abstract] [Full Text] [Related]

  • 19. Detection breadth and limits for potential adventitious/endogenous contaminants in biopharmaceutical processes: a reality check for innovative methods.
    Duncan P, McKerral L, Feng S, Tsai PK.
    Dev Biol (Basel); 2006 Mar; 126():283-90; discussion 327. PubMed ID: 17058504
    [Abstract] [Full Text] [Related]

  • 20. An overview of quantitative PCR assays for biologicals: quality and safety evaluation.
    Xu Y, Brorson K.
    Dev Biol (Basel); 2003 Mar; 113():89-98. PubMed ID: 14620857
    [Abstract] [Full Text] [Related]

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