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Journal Abstract Search

654 related items for PubMed ID: 18993008

  • 1. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products.
    Shankar G, Devanarayan V, Amaravadi L, Barrett YC, Bowsher R, Finco-Kent D, Fiscella M, Gorovits B, Kirschner S, Moxness M, Parish T, Quarmby V, Smith H, Smith W, Zuckerman LA, Koren E.
    J Pharm Biomed Anal; 2008 Dec 15; 48(5):1267-81. PubMed ID: 18993008
    [Abstract] [Full Text] [Related]

  • 2. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products.
    Mire-Sluis AR, Barrett YC, Devanarayan V, Koren E, Liu H, Maia M, Parish T, Scott G, Shankar G, Shores E, Swanson SJ, Taniguchi G, Wierda D, Zuckerman LA.
    J Immunol Methods; 2004 Jun 15; 289(1-2):1-16. PubMed ID: 15251407
    [Abstract] [Full Text] [Related]

  • 3. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products.
    Koren E, Smith HW, Shores E, Shankar G, Finco-Kent D, Rup B, Barrett YC, Devanarayan V, Gorovits B, Gupta S, Parish T, Quarmby V, Moxness M, Swanson SJ, Taniguchi G, Zuckerman LA, Stebbins CC, Mire-Sluis A.
    J Immunol Methods; 2008 Apr 20; 333(1-2):1-9. PubMed ID: 18275969
    [Abstract] [Full Text] [Related]

  • 4. Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics.
    Gupta S, Indelicato SR, Jethwa V, Kawabata T, Kelley M, Mire-Sluis AR, Richards SM, Rup B, Shores E, Swanson SJ, Wakshull E.
    J Immunol Methods; 2007 Apr 10; 321(1-2):1-18. PubMed ID: 17307199
    [Abstract] [Full Text] [Related]

  • 5. Regulatory considerations for development of bioanalytical assays for biotechnology products.
    Swann PG, Shapiro MA.
    Bioanalysis; 2011 Mar 10; 3(6):597-603. PubMed ID: 21417729
    [Abstract] [Full Text] [Related]

  • 6. How to systematically evaluate immunogenicity of therapeutic proteins - regulatory considerations.
    Jahn EM, Schneider CK.
    N Biotechnol; 2009 Jun 10; 25(5):280-6. PubMed ID: 19491045
    [Abstract] [Full Text] [Related]

  • 7. Scientific and regulatory considerations on the immunogenicity of biologics.
    Shankar G, Shores E, Wagner C, Mire-Sluis A.
    Trends Biotechnol; 2006 Jun 10; 24(6):274-80. PubMed ID: 16631266
    [Abstract] [Full Text] [Related]

  • 8. An overview of scientific and regulatory issues for the immunogenicity of biological products.
    Chamberlain P, Mire-Sluis AR.
    Dev Biol (Basel); 2003 Jun 10; 112():3-11. PubMed ID: 12762499
    [Abstract] [Full Text] [Related]

  • 9. The challenges of immunogenicity in developing biosimilar products.
    Wadhwa M, Thorpe R.
    IDrugs; 2009 Jul 10; 12(7):440-4. PubMed ID: 19579165
    [Abstract] [Full Text] [Related]

  • 10. Challenges with current technology for the detection, measurement and characterization of antibodies against biological therapeutics.
    Mire-Sluis AR.
    Dev Biol (Basel); 2002 Jul 10; 109():59-69. PubMed ID: 12434914
    [Abstract] [Full Text] [Related]

  • 11. Recommendations for the validation of cell-based assays used for the detection of neutralizing antibody immune responses elicited against biological therapeutics.
    Gupta S, Devanarayan V, Finco D, Gunn GR, Kirshner S, Richards S, Rup B, Song A, Subramanyam M.
    J Pharm Biomed Anal; 2011 Jul 15; 55(5):878-88. PubMed ID: 21531522
    [Abstract] [Full Text] [Related]

  • 12. Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies.
    Geng D, Shankar G, Schantz A, Rajadhyaksha M, Davis H, Wagner C.
    J Pharm Biomed Anal; 2005 Sep 15; 39(3-4):364-75. PubMed ID: 15963677
    [Abstract] [Full Text] [Related]

  • 13. Detection, measurement and characterization of unwanted antibodies induced by therapeutic biologicals.
    Wadhwa M, Gaines-Das R, Thorpe R, Mire-Sluis A.
    Dev Biol (Basel); 2005 Sep 15; 122():155-70. PubMed ID: 16375260
    [Abstract] [Full Text] [Related]

  • 14. Sample size consideration for immunoassay screening cut-point determination.
    Zhang J, Zhang L, Yang H.
    J Biopharm Stat; 2014 Sep 15; 24(3):535-45. PubMed ID: 24697778
    [Abstract] [Full Text] [Related]

  • 15. Comparison of competitive ligand-binding assay and bioassay formats for the measurement of neutralizing antibodies to protein therapeutics.
    Finco D, Baltrukonis D, Clements-Egan A, Delaria K, Gunn GR, Lowe J, Maia M, Wong T.
    J Pharm Biomed Anal; 2011 Jan 25; 54(2):351-8. PubMed ID: 20863644
    [Abstract] [Full Text] [Related]

  • 16. A formal comparison of different methods for establishing cut points to distinguish positive and negative samples in immunoassays.
    Jaki T, Lawo JP, Wolfsegger MJ, Singer J, Allacher P, Horling F.
    J Pharm Biomed Anal; 2011 Jul 15; 55(5):1148-56. PubMed ID: 21561734
    [Abstract] [Full Text] [Related]

  • 17. Nonclinical development of biopharmaceuticals.
    Baumann A.
    Drug Discov Today; 2009 Dec 15; 14(23-24):1112-22. PubMed ID: 19853058
    [Abstract] [Full Text] [Related]

  • 18. Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies.
    Ponce R, Abad L, Amaravadi L, Gelzleichter T, Gore E, Green J, Gupta S, Herzyk D, Hurst C, Ivens IA, Kawabata T, Maier C, Mounho B, Rup B, Shankar G, Smith H, Thomas P, Wierda D.
    Regul Toxicol Pharmacol; 2009 Jul 15; 54(2):164-82. PubMed ID: 19345250
    [Abstract] [Full Text] [Related]

  • 19. Challenges in developing antidrug antibody screening assays.
    Dodge R, Daus C, Yaskanin D.
    Bioanalysis; 2009 Jul 15; 1(4):699-704. PubMed ID: 21083131
    [Abstract] [Full Text] [Related]

  • 20. Bioanalytical considerations in the comparability assessment of biotherapeutics.
    Lee JW, Wang YM, Moxness M, DeSilva B.
    Bioanalysis; 2011 Mar 15; 3(6):613-22. PubMed ID: 21417731
    [Abstract] [Full Text] [Related]

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