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

Author/s:Davit, Barbara; Chen, Meiling; Conner, Dale; Haidar, Sam; Kim, Stephanie; Lee, Christina; Lionberger, Robert; Makhlouf, Fairouz; Nwakama, Patrick; Patel, Devvrat; Schuirmann, Donald; Yu, Lawrence

Date:07/04/2005

Journal:AAPS J

DOI:10.1208/s12248-012-9406-x