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Agency Guidelines for Recombinant Biosimilars of Biopharmaceuticals.

Authors :
Wilkinson, Diane
Krull, Ira S.
Rathore, Anurag
Source :
LC-GC North America. Jan2017, Vol. 35 Issue 1, p36-44. 8p.
Publication Year :
2017

Abstract

All agencies have issued varying guidances for the approval of recombinant biosimilars of biopharmaceuticals, and all submittals are considered on a case-by-case basis. This installment of "Focus on Biopharmaceutical Analysis" looks at the best methodologies for demonstrating their analytical comparability. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
15275949
Volume :
35
Issue :
1
Database :
Academic Search Index
Journal :
LC-GC North America
Publication Type :
Periodical
Accession number :
120926694