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Journal Abstract Search

179 related items for PubMed ID: 31858313

  • 1. Current Perspectives on Ligand-Binding Assay Practices in the Quantification of Circulating Therapeutic Proteins for Biosimilar Biological Product Development.
    Thway TM, Wang YM, Booth BP, Maxfield K, Huang SM, Zineh I.
    AAPS J; 2019 Dec 19; 22(1):15. PubMed ID: 31858313
    [Abstract] [Full Text] [Related]

  • 2. Retrospective Analysis of Bioanalytical Method Validation Approaches in Biosimilar Biological Product Development.
    Obianom ON, Thway TM, Schrieber SJ, Okusanya OO, Wang YM, Huang SM, Zineh I.
    AAPS J; 2019 Sep 11; 21(6):105. PubMed ID: 31512109
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  • 3. Bioanalytical strategy used in development of pharmacokinetic (PK) methods that support biosimilar programs.
    Colbert A, Umble-Romero A, Prokop S, Chow VF, Wong T, DeSimone D, Zhou L, Pederson S.
    MAbs; 2014 Sep 11; 6(5):1178-89. PubMed ID: 25517303
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  • 4. 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 11; 16(6):1149-58. PubMed ID: 25277165
    [Abstract] [Full Text] [Related]

  • 5. A Simulation Approach to Evaluate the Impact of Patterns of Bioanalytical Bias Difference on the Outcome of Pharmacokinetic Similarity Studies.
    Obianom ON, Okusanya OO, Earp J, Thway TM.
    Clin Pharmacol Ther; 2020 Jul 11; 108(1):107-115. PubMed ID: 31957006
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  • 7. Bioanalytical challenges of biosimilars.
    Islam R.
    Bioanalysis; 2014 Feb 11; 6(3):349-56. PubMed ID: 24471955
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  • 8. International standards for monoclonal antibodies to support pre- and post-marketing product consistency: Evaluation of a candidate international standard for the bioactivities of rituximab.
    Prior S, Hufton SE, Fox B, Dougall T, Rigsby P, Bristow A, participants of the study.
    MAbs; 2018 Jan 11; 10(1):129-142. PubMed ID: 28985159
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  • 14. Challenges in bioanalytical assays for biosimilars.
    Wang X, Chen L.
    Bioanalysis; 2014 Aug 11; 6(16):2111-3. PubMed ID: 25331854
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  • 17. Regulatory considerations for development of bioanalytical assays for biotechnology products.
    Swann PG, Shapiro MA.
    Bioanalysis; 2011 Mar 11; 3(6):597-603. PubMed ID: 21417729
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  • 18. Demonstrating biosimilar and originator antidrug antibody binding comparability in antidrug antibody assays: a practical approach.
    Ryding J, Stahl M, Ullmann M.
    Bioanalysis; 2017 Sep 11; 9(18):1395-1406. PubMed ID: 28920451
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  • 19. Role of Modeling and Simulation in the Development of Novel and Biosimilar Therapeutic Proteins.
    Wang YC, Wang Y, Schrieber SJ, Earp J, Thway TM, Huang SM, Zineh I, Christl L.
    J Pharm Sci; 2019 Jan 11; 108(1):73-77. PubMed ID: 30395832
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