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295 related items for PubMed ID: 29285735

  • 1. Recommendations for the Development and Validation of Neutralizing Antibody Assays in Support of Biosimilar Assessment.
    Gouty D, Cai CC, Cai XY, Kasinath A, Kumar V, Alvandkouhi S, Yang J, Pederson S, Babbitt B, Peritt D, Rudy A, Koppenburg V, Dasilva A, Ullmann M, Liu S, Satterwhite C.
    AAPS J; 2017 Dec 28; 20(1):25. PubMed ID: 29285735
    [Abstract] [Full Text] [Related]

  • 2. Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs.
    Civoli F, Kasinath A, Cai XY, Wadhwa M, Exley A, Oldfield P, Alvandkouhi S, Schaffar G, Chappell J, Bowsher R, Devanarayan V, Marini J, Rebarchak S, Anderson M, Koppenburg V, Lester T.
    AAPS J; 2019 Dec 02; 22(1):7. PubMed ID: 31792633
    [Abstract] [Full Text] [Related]

  • 3. Systematic verification of bioanalytical similarity between a biosimilar and a reference biotherapeutic: committee recommendations for the development and validation of a single ligand-binding assay to support pharmacokinetic assessments.
    Marini JC, Anderson M, Cai XY, Chappell J, Coffey T, Gouty D, Kasinath A, Koppenburg V, Oldfield P, Rebarchak S, Bowsher RR.
    AAPS J; 2014 Nov 02; 16(6):1149-58. PubMed ID: 25277165
    [Abstract] [Full Text] [Related]

  • 4. Challenges of developing and validating immunogenicity assays to support comparability studies for biosimilar drug development.
    Cai XY, Thomas J, Cullen C, Gouty D.
    Bioanalysis; 2012 Sep 02; 4(17):2169-77. PubMed ID: 23013399
    [Abstract] [Full Text] [Related]

  • 5. Analytic characterization of biosimilars.
    Sullivan PM, DiGrazia LM.
    Am J Health Syst Pharm; 2017 Apr 15; 74(8):568-579. PubMed ID: 28389456
    [Abstract] [Full Text] [Related]

  • 6. Comparison of cell-based and non-cell-based assay platforms for the detection of clinically relevant anti-drug neutralizing antibodies for immunogenicity assessment of therapeutic proteins.
    Hu J, Wala I, Han H, Nagatani J, Barger T, Civoli F, Kaliyaperumal A, Zhuang Y, Gupta S.
    J Immunol Methods; 2015 Apr 15; 419():1-8. PubMed ID: 25795420
    [Abstract] [Full Text] [Related]

  • 7. Development and validation of cell-based assays for the detection of neutralizing antibodies to drug products: a practical approach.
    Jolicoeur P, Tacey RL.
    Bioanalysis; 2012 Dec 15; 4(24):2959-70. PubMed ID: 23244285
    [Abstract] [Full Text] [Related]

  • 8. A comparative multi-tiered immunogenicity assessment of biosimilar pegylated filgrastim: validation of methods for clinical assessment of INTP5.
    Hajela P, Patel R, Kale P, Kumar M, Khambhampaty S.
    Expert Opin Biol Ther; 2022 Feb 15; 22(2):321-330. PubMed ID: 34794342
    [Abstract] [Full Text] [Related]

  • 9. Bioanalytical challenges of biosimilars.
    Islam R.
    Bioanalysis; 2014 Feb 15; 6(3):349-56. PubMed ID: 24471955
    [Abstract] [Full Text] [Related]

  • 10. Demonstrating biosimilar and originator antidrug antibody binding comparability in antidrug antibody assays: a practical approach.
    Ryding J, Stahl M, Ullmann M.
    Bioanalysis; 2017 Sep 15; 9(18):1395-1406. PubMed ID: 28920451
    [Abstract] [Full Text] [Related]

  • 11. Strategies to Determine Assay Format for the Assessment of Neutralizing Antibody Responses to Biotherapeutics.
    Wu B, Chung S, Jiang XR, McNally J, Pedras-Vasconcelos J, Pillutla R, White JT, Xu Y, Gupta S.
    AAPS J; 2016 Nov 15; 18(6):1335-1350. PubMed ID: 27495119
    [Abstract] [Full Text] [Related]

  • 12. Contribution of animal studies to evaluate the similarity of biosimilars to reference products.
    van Meer PJ, Ebbers HC, Kooijman M, Gispen-de Wied CC, Silva-Lima B, Moors EH, Schellekens H.
    Drug Discov Today; 2015 Apr 15; 20(4):483-90. PubMed ID: 25463036
    [Abstract] [Full Text] [Related]

  • 13. Development of biosimilars.
    Al-Sabbagh A, Olech E, McClellan JE, Kirchhoff CF.
    Semin Arthritis Rheum; 2016 Apr 15; 45(5 Suppl):S11-8. PubMed ID: 26947440
    [Abstract] [Full Text] [Related]

  • 14. Comparative immunogenicity assessment: a critical consideration for biosimilar development.
    Liu PM, Zou L, Sadhu C, Shen WD, Nock S.
    Bioanalysis; 2015 Apr 15; 7(3):373-81. PubMed ID: 25697194
    [Abstract] [Full Text] [Related]

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  • 17. 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]

  • 18. Understanding the biosimilar approval and extrapolation process-A case study of an epoetin biosimilar.
    Agarwal AB, McBride A.
    Crit Rev Oncol Hematol; 2016 Aug 25; 104():98-107. PubMed ID: 27317353
    [Abstract] [Full Text] [Related]

  • 19. Biosimilar monoclonal antibodies: preclinical and clinical development aspects.
    Gonçalves J, Araújo F, Cutolo M, Fonseca JE.
    Clin Exp Rheumatol; 2016 Aug 25; 34(4):698-705. PubMed ID: 27383278
    [Abstract] [Full Text] [Related]

  • 20. Progress in biosimilar monoclonal antibody development: the infliximab biosimilar CT-P13 in the treatment of rheumatic diseases.
    Braun J, Kudrin A.
    Immunotherapy; 2015 Aug 25; 7(2):73-87. PubMed ID: 25713985
    [Abstract] [Full Text] [Related]

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