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
Journal Title: The AAPS Journal - Year 2014, Vol 16, Issue 6
Abstract
The online version of this article (doi:10.1208/s12248-014-9669-5) contains supplementary material, which is available to authorized users.
Authors and Affiliations
Joseph C. Marini, Michael Anderson, Xiao-Yan Cai, John Chappell, Todd Coffey, Dominique Gouty, Aparna Kasinath, Vera Koppenburg, Philip Oldfield, Shannon Rebarchak, Ronald R. Bowsher
Keywords
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- EP ID EP681721
- DOI 10.1208/s12248-014-9669-5
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