Completeness Assessment of Type II Active Pharmaceutical Ingredient Drug Master Files under Generic Drug User Fee Amendment: Review Metrics and Common Incomplete Items
Author/s:Zhang, Huyi; Li, Haitao; Song, Wei; Shen, Diandian; Skanchy, David; Shen, Kun; Lionberger, Robert; Rosencrance, Susan; Yu, Lawrence
Date:07/06/2005
Journal:AAPS J
DOI:10.1208/s12248-014-9630-7