An Exact Procedure for the Evaluation of Reference-Scaled Average Bioequivalence Journal title: The AAPS Journal Authors: Laszlo Tothfalusi, Laszlo Endrenyi Subject(s): Medicine
Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration Journal title: The AAPS Journal Authors: Barbara M. Davit, Mei-Ling Chen, Dale P. Conner, Sam H. Haidar, Stephanie Kim, Christina H. Lee, Rob... Subject(s): Medicine
Highly Variable Drugs: Observations from Bioequivalence Data Submitted to the FDA for New Generic Drug Applications Journal title: The AAPS Journal Authors: Barbara M. Davit, Dale P. Conner, Beth Fabian-Fritsch, Sam H. Haidar, Xiaojian Jiang, Devvrat T. Pat... Subject(s): Medicine
Evaluation of a Scaling Approach for the Bioequivalence of Highly Variable Drugs Journal title: The AAPS Journal Authors: Sam H. Haidar, Fairouz Makhlouf, Donald J. Schuirmann, Terry Hyslop, Barbara Davit, Dale Conner, Law... Subject(s): Medicine