Implementation of a Reference-Scaled Average Bioequivalence...

The AAPS Journal 2012 / 12 Vol. 14; Iss. 4

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

Davit, Barbara M., Chen, Mei-Ling, Conner, Dale P., Haidar, Sam H., Kim, Stephanie, Lee, Christina H., Lionberger, Robert A., Makhlouf, Fairouz T., Nwakama, Patrick E., Patel, Devvrat T., Schuirmann,
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Volume:
14
Language:
english
Pages:
10
Journal:
The AAPS Journal
DOI:
10.1208/s12248-012-9406-x
Date:
December, 2012
File:
PDF, 404 KB
english, 2012
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