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Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration

Barbara M. Davit; Mei-Ling Chen; Dale P. Conner; Sam H. Haidar; Stephanie Kim; Christina H. Lee; Robert A. Lionberger; Fairouz T. Makhlouf; Patrick E. Nwakama; Devvrat T. Patel; Donald J. Schuirmann; Lawrence X. Yu
The AAPS Journal · Vol. 14, Issue 4 · pp. 915-924 · 2012
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Bibliographic Information

JournalThe AAPS Journal
PublisherSpringer
Publication Date2012-12-01
Publication Year2012
Volume14
Issue4
Pages915-924
Document TypeJournal Article
eISSN1550-7416
DOI10.1208/s12248-012-9406-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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