Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration
美国食品药品监督管理局对高度可变仿制药产品实施参考标度平均生物等效性方法
期刊:AAPS Journal
影响因子:3.7
doi:10.1208/s12248-012-9406-x
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
