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Journal Abstract Search

201 related items for PubMed ID: 28920451

  • 1. Demonstrating biosimilar and originator antidrug antibody binding comparability in antidrug antibody assays: a practical approach.
    Ryding J, Stahl M, Ullmann M.
    Bioanalysis; 2017 Sep; 9(18):1395-1406. PubMed ID: 28920451
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  • 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
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  • 3. 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
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  • 5. 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
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  • 6. 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 28; 16(6):1149-58. PubMed ID: 25277165
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  • 7. A survey of pharmacokinetic bioanalytical methods in biosimilar biological license applications for the assessment of target and antidrug antibody effects.
    Hackel DT, Thway TM, Huang SM, Wang YC.
    Bioanalysis; 2021 Sep 28; 13(17):1323-1332. PubMed ID: 34515515
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  • 8. The use of pharmacometrics to optimize biosimilar development.
    Dodds M, Chow V, Markus R, Pérez-Ruixo JJ, Shen D, Gibbs M.
    J Pharm Sci; 2013 Nov 28; 102(11):3908-14. PubMed ID: 24027111
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  • 13. Biosimilars and biobetters as tools for understanding and mitigating the immunogenicity of biotherapeutics.
    Barbosa MD, Kumar S, Loughrey H, Singh SK.
    Drug Discov Today; 2012 Dec 28; 17(23-24):1282-8. PubMed ID: 22796124
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  • 18. Comparability of Antibody-Mediated Cell Killing Activity Between a Proposed Biosimilar RTXM83 and the Originator Rituximab.
    Cuello HA, Segatori VI, Alberto M, Pesce A, Alonso DF, Gabri MR.
    BioDrugs; 2016 Jun 28; 30(3):225-31. PubMed ID: 27053342
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  • 19. Clinical development and trial design of biosimilar products: a Japanese perspective.
    Nagasaki M, Ando Y.
    J Biopharm Stat; 2014 Jun 28; 24(6):1165-72. PubMed ID: 25033370
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