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Journal Abstract Search

359 related items for PubMed ID: 18181718

  • 1. 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]

  • 2. Environmental assessment requirements for live biological drugs.
    Sutton A.
    Clin Infect Dis; 2008 Feb 01; 46 Suppl 2():S112-4; discussion S144-51. PubMed ID: 18181713
    [Abstract] [Full Text] [Related]

  • 3. Control of manufacture--principles and purposes.
    Luff PR.
    Dev Biol Stand; 1992 Feb 01; 79():155-8. PubMed ID: 1286749
    [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 Feb 01; 122():139-44. PubMed ID: 16375258
    [Abstract] [Full Text] [Related]

  • 5. Development of probiotics as biologic drugs.
    Hoffman FA.
    Clin Infect Dis; 2008 Feb 01; 46 Suppl 2():S125-7; discussion S144-51. PubMed ID: 18181717
    [Abstract] [Full Text] [Related]

  • 6. 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
    [Abstract] [Full Text] [Related]

  • 7. Preclinical testing in the development of probiotics: a regulatory perspective with Bacillus strains as an example.
    Sorokulova I.
    Clin Infect Dis; 2008 Feb 01; 46 Suppl 2():S92-5; discussion S144-51. PubMed ID: 18181731
    [Abstract] [Full Text] [Related]

  • 8. Current good tissue practice for human cell, tissue, and cellular and tissue-based product establishments; inspection and enforcement. Final rule.
    Food and Drug Administration, HHS.
    Fed Regist; 2004 Nov 24; 69(226):68611-88. PubMed ID: 15562555
    [Abstract] [Full Text] [Related]

  • 9. Control of recombinant DNA produced pharmaceuticals by a combination of process validation and final product specifications.
    Jones AJ, O'Connor JV.
    Dev Biol Stand; 1985 Nov 24; 59():175-80. PubMed ID: 4007276
    [Abstract] [Full Text] [Related]

  • 10. Clinical research on probiotics: the interface between science and regulation.
    Tamayo C.
    Clin Infect Dis; 2008 Feb 01; 46 Suppl 2():S101-3; discussion S144-51. PubMed ID: 18181711
    [Abstract] [Full Text] [Related]

  • 11. Potential use of the scan statistic for quality control in blood product manufacturing.
    Lachenbruch PA, Foulkes MA, Williams AE, Epstein JS.
    J Biopharm Stat; 2005 Feb 01; 15(2):353-66. PubMed ID: 15796300
    [Abstract] [Full Text] [Related]

  • 12. How do we assure the quality of biological medicines?
    Longstaff C, Whitton CM, Stebbings R, Gray E.
    Drug Discov Today; 2009 Jan 01; 14(1-2):50-5. PubMed ID: 18951998
    [Abstract] [Full Text] [Related]

  • 13. Control of manufacture--the EC point of view.
    Meyer P.
    Dev Biol Stand; 1992 Jan 01; 79():159-62. PubMed ID: 1286750
    [No Abstract] [Full Text] [Related]

  • 14. Probiotics in the United States.
    Vanderhoof JA, Young R.
    Clin Infect Dis; 2008 Feb 01; 46 Suppl 2():S67-72; discussion S144-51. PubMed ID: 18181726
    [Abstract] [Full Text] [Related]

  • 15. WHO Expert Committee on Biological Standardization.
    World Health Organ Tech Rep Ser; 2002 Feb 01; 904():i-vi, 1-107. PubMed ID: 11980231
    [Abstract] [Full Text] [Related]

  • 16. [Assessment of probiotics according to the international organizations (FAO/WHO)].
    Liaskovskiĭ TM, Podgorskiĭ VS.
    Mikrobiol Z; 2005 Feb 01; 67(6):104-12. PubMed ID: 16493892
    [Abstract] [Full Text] [Related]

  • 17. PAT for vaccines: the first stage of PAT implementation for development of a well-defined whole-cell vaccine against whooping cough disease.
    Streefland M, van de Waterbeemd B, Happé H, van der Pol LA, Beuvery EC, Tramper J, Martens DE.
    Vaccine; 2007 Apr 20; 25(16):2994-3000. PubMed ID: 17313999
    [Abstract] [Full Text] [Related]

  • 18. Recommendations and requirements for the design of bioanalytical testing used in comparability studies for biosimilar drug development.
    Cai XY, Gouty D, Baughman S, Ramakrishnan M, Cullen C.
    Bioanalysis; 2011 Mar 20; 3(5):535-40. PubMed ID: 21388266
    [Abstract] [Full Text] [Related]

  • 19. Presentation of the EEC directive (81/852)--quality.
    Lee AM.
    Dev Biol Stand; 1992 Mar 20; 79():39-41. PubMed ID: 1286763
    [Abstract] [Full Text] [Related]

  • 20. Risk reduction in biotherapeutic products.
    Ill CR, Dehghani H.
    Curr Opin Drug Discov Devel; 2009 Mar 20; 12(2):296-304. PubMed ID: 19333875
    [Abstract] [Full Text] [Related]

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