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Recommendations for the Development and Validation of Neutralizing Antibody Assays in Support of Biosimilar Assessment.
AAPS J. 2017 Dec 28;20(1):25. doi: 10.1208/s12248-017-0181-6.
AAPS J. 2017.
PMID: 29285735
Review.
Correction to: 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.
Gouty D, et al. Among authors: kasinath a.
AAPS J. 2018 Feb 27;20(2):38. doi: 10.1208/s12248-018-0189-6.
AAPS J. 2018.
PMID: 29488021
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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 JC, Anderson M, Cai XY, Chappell J, Coffey T, Gouty D, Kasinath A, Koppenburg V, Oldfield P, Rebarchak S, Bowsher RR.
Marini JC, et al. Among authors: kasinath a.
AAPS J. 2014 Nov;16(6):1149-58. doi: 10.1208/s12248-014-9669-5. Epub 2014 Oct 3.
AAPS J. 2014.
PMID: 25277165
Free PMC article.
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Erratum to: 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.
Marini JC, et al. Among authors: kasinath a.
AAPS J. 2017 May;19(3):883. doi: 10.1208/s12248-017-0074-8.
AAPS J. 2017.
PMID: 28374318
No abstract available.
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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.
Civoli F, et al. Among authors: kasinath a.
AAPS J. 2019 Dec 2;22(1):7. doi: 10.1208/s12248-019-0386-y.
AAPS J. 2019.
PMID: 31792633
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