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Journal Abstract Search

79 related items for PubMed ID: 1478340

  • 1. Applicability of statistical reliability methods to the validation process.
    Koch GG.
    Dev Biol Stand; 1992; 76():225-9. PubMed ID: 1478340
    [Abstract] [Full Text] [Related]

  • 2. Validation of a computer software program for statistical analysis of accelerated stability studies on biological standards.
    Shin J, Nam J.
    Biologicals; 2007 Mar; 35(1):27-30. PubMed ID: 16580228
    [Abstract] [Full Text] [Related]

  • 3. Philosophy and goals of validation for biotech products and the relevance of scale.
    Hageman TC.
    Dev Biol Stand; 1992 Mar; 76():231-7. PubMed ID: 1478341
    [Abstract] [Full Text] [Related]

  • 4. Validation of tests methods in the quality control of biologicals.
    Hendriksen CF.
    Dev Biol Stand; 1999 Mar; 101():217-21. PubMed ID: 10566796
    [Abstract] [Full Text] [Related]

  • 5. 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]

  • 6. Strategies for the validation of viral inactivation in biologic products.
    Aronson DL.
    Prog Clin Biol Res; 1990 Mar; 324():137-49. PubMed ID: 2408050
    [No Abstract] [Full Text] [Related]

  • 7. Use of a statistical strategy to evaluate sources of variability in viral safety experiments for a recombinant biopharmaceutical.
    McAllister PR, Shadle PJ, Smith TM, Scott RG, Lubiniecki AS.
    Dev Biol Stand; 1996 Mar; 88():111-21. PubMed ID: 9119122
    [No Abstract] [Full Text] [Related]

  • 8. Process validation.
    Beatrice MG.
    Dev Biol Stand; 1998 Mar; 96():169-71; discussion 177-9. PubMed ID: 9890529
    [No Abstract] [Full Text] [Related]

  • 9. Viral safety evaluation of plasma-derived therapeutic products.
    Farshid M.
    Dev Biol (Basel); 2004 Mar; 118():11-5. PubMed ID: 15645668
    [Abstract] [Full Text] [Related]

  • 10. Viral validation design of a manufacturing process.
    Larzul D.
    Dev Biol Stand; 1999 Mar; 99():139-50. PubMed ID: 10404885
    [Abstract] [Full Text] [Related]

  • 11. Relationships among product characterization, process validation and preclinical/clinical studies for well-characterized products.
    Lubiniecki AS.
    Dev Biol Stand; 1998 Mar; 96():173-5; discussion 177-9. PubMed ID: 9890530
    [No Abstract] [Full Text] [Related]

  • 12. CBER: new approaches to biological product testing.
    Donlon JA.
    Dev Biol Stand; 1999 Mar; 101():21-5. PubMed ID: 10566770
    [Abstract] [Full Text] [Related]

  • 13. Validation of virus removal in large scale purification processes.
    Fritsch E.
    Dev Biol Stand; 1992 Mar; 76():239-48. PubMed ID: 1478342
    [No Abstract] [Full Text] [Related]

  • 14. Viral safety of biological products and the concept of validation.
    Horaud F.
    Dev Biol Stand; 1996 Mar; 88():19-24. PubMed ID: 9119135
    [No Abstract] [Full Text] [Related]

  • 15. Virus validation procedures: practical aspects.
    Minor PD.
    Blood Coagul Fibrinolysis; 1995 Jul; 6 Suppl 2():S10-2. PubMed ID: 7495959
    [Abstract] [Full Text] [Related]

  • 16. Considerations in performing virus spiking experiments and process validation studies.
    Darling AJ.
    Dev Biol Stand; 1993 Jul; 81():221-9. PubMed ID: 8174806
    [Abstract] [Full Text] [Related]

  • 17. Reliability of nutritional screening and assessment tools.
    Jones JM.
    Nutrition; 2004 Mar; 20(3):307-11. PubMed ID: 14990273
    [Abstract] [Full Text] [Related]

  • 18. Experience with validation of clinical trial materials: an inspector's viewpoint.
    Wolfe L.
    Dev Biol (Basel); 2003 Mar; 113():27-33. PubMed ID: 14620849
    [Abstract] [Full Text] [Related]

  • 19. Sources of variation in biomarkers.
    Vineis P.
    IARC Sci Publ; 1997 Mar; (142):59-71. PubMed ID: 9354912
    [Abstract] [Full Text] [Related]

  • 20. 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 Mar; 59():175-80. PubMed ID: 4007276
    [Abstract] [Full Text] [Related]

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