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Specific Method Validation and Sample Analysis Approaches for Biocomparability Studies of Denosumab Addressing Method and Manufacture Site Changes

Ramak Pourvasei; Ed Lee; Michael Eschenberg; Vimal Patel; Chris Macaraeg; Kinnari Pandya; Judy Shih; Mark Ma; Jean W. Lee; Binodh DeSilva
The AAPS Journal · Vol. 15, Issue 1 · pp. 70-77 · 2013
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Bibliographic Information

JournalThe AAPS Journal
PublisherSpringer
Publication Date2013-01-01
Publication Year2013
Volume15
Issue1
Pages70-77
Document TypeJournal Article
eISSN1550-7416
DOI10.1208/s12248-012-9414-x

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NARA Access Coverage1999-01-01~Current
Journal Homepagehttps://www.springer.com/journal/12248
Publisher PageOpen Publisher Page
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