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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: cai xy. 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.
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: cai xy. AAPS J. 2017 May;19(3):883. doi: 10.1208/s12248-017-0074-8. AAPS J. 2017. PMID: 28374318 No abstract available.
383 results