Biosimilar Publications
Publications

Biosimilars

Industry Publications from BioAgilytix’s Expert Scientists

Explore the list of recent biosimilar publications to which BioAgilytix’s scientists have contributed:

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 (2020) 22: 7. doi: 10.1208/s12248-019-0386-y.
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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. doi: 10.1208/s12248-017-0181-6.
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Meeting the Rigorous Demands of Biosimilar Pharmacokinetics
Mansouri S, Zemo J, Alligood K. International Journal of Pharmacokinetics 2017 Jan; DOI 10.4155/ipk-2016-0024
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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 J, Anderson M, Cai XY, Chappell J, Coffey T, Gouty D, Kasinath A, Koppenburg V, Oldfield P, Rebarchak S, Bowsher R. AAPS J. 2014 Nov; 16(6). doi: 10.1208/s12248-014-9669-5
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Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development.
Cai XY, Wake A, Gouty D. Bioanalysis. 2013 Mar; 5(5):517-20. doi: 10.4155/bio.13.1.
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Recommendations and requirements for the design of bioanalytical testing used in comparability studies for biosimilar drug development.
Cai XY, Gouty D, Baughman S, Ramakrishnan M, Cullen C. Bioanalysis. 2011 Mar; 3(5):535-40. doi: 10.4155/bio.11.24. Review.
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