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Rational Selection, Criticality Assessment, and Tiering of Quality Attributes and Test Methods for Analytical Similarity Evaluation of Biosimilars

Crossref DOI link: https://doi.org/10.1208/s12248-018-0230-9

Published Online: 2018-05-10

Published Print: 2018-07

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Vandekerckhove, Kristof

Seidl, Andreas

Gutka, Hiten

Kumar, Manish

Gratzl, Gyöngyi

Keire, David

Coffey, Todd

Kuehne, Henriette https://orcid.org/0000-0002-9802-9033
License Information

Text and Data Mining valid from 2018-05-10
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Article History

Received: 13 February 2018

Accepted: 26 March 2018

First Online: 10 May 2018

Compliance with Ethical Standards

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: This article reflects the views of the authors and should not be construed to represent FDA’s views or policies.