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