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. 2014 Nov 1;6(5):1178–1189. doi: 10.4161/mabs.32114

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© 2014 The Author(s). Published with license by Taylor & Francis Group, LLC

© Alex Colbert, Amber Umble-Romero, Samantha Prokop, Vincent Fung-Sing Chow, Teresa Wong, Danielle DeSimone, Lei Zhou, and Susan Pederson

This is an Open Access article distributed under the terms of the Creative Commons Attribution-Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. The moral rights of the named author(s) have been asserted.

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Figure 8. — Selectivity was evaluated in the human PK prototype assay to determine if there were any significant recovery differences from human serum matrix across the three test products. Each of the test products were spiked into 6 individual normal human serum donors at the assay LLOQ (50ng/mL), and recovery of the three test products across donors were all within ± 11% of nominal. There were no matrix effects observed in human serum with the biosimilar, FDA-licensed, or EU-authorized reference products.