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

✍ Scribed by 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, Donald J.; Yu, Lawrence X.

• Book ID: 115500923
• Publisher: American Association of Pharmaceutical Scientists
• Year: 2012
• Tongue: English
• Weight: 404 KB
• Volume: 14
• Category: Article
• ISSN: 1550-7416
• DOI: 10.1208/s12248-012-9406-x