Completeness Assessment of Type II Active Pharmaceutical Ingredient Drug Master Files under Generic Drug User Fee Amendment: Review Metrics and Common Incomplete Items

Por Zhang, Huyi, Li, Haitao, Song, Wei, Shen, Diandian, Skanchy, David, Shen, Kun, Lionberger, Robert A., Rosencrance, Susan M., Yu, Lawrence X.
Publicado em 2014