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Practical considerations for demonstrating drug-substance uniformity for biological products

Authors :
Abraham, Sushil
Rydholm, Eric
Wagner, Phil
Source :
Biopharm International. April 2011, Vol. 24 Issue 4, p30, 7 p.
Publication Year :
2011

Abstract

Drug-substance uniformity is an important consideration for the final step in the manufacture of drug substance/active pharmaceutical ingredient. Uniformity studies are necessary to ensure that the entire contents of the [...]

Subjects

Subjects :
Biological products

Details

Language :
English
ISSN :
1542166X
Volume :
24
Issue :
4
Database :
Gale General OneFile
Journal :
Biopharm International
Publication Type :
Periodical
Accession number :
edsgcl.259467829