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

Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference

Por Yu, Lawrence X., Baker, Jeffrey, Berlam, Susan C., Boam, Ashley, Brandreth, E. J., Buhse, Lucinda, Cosgrove, Thomas, Doleski, David, Ensor, Lynne, Famulare, Joseph, Ganapathy, Mohan, Grampp, Gustavo, Hussong, David, Iser, Robert, Johnston, Gordon, Kesisoglou, Filippos, Khan, Mansoor, Kozlowski, Steven, Lacana, Emanuela, Lee, Sau L., Miller, Stephen, Miksinski, Sarah Pope, Moore, Christine M. V., Mullin, Theresa, Raju, G. K., Raw, Andre, Rosencrance, Susan, Rosolowsky, Mark, Stinavage, Paul, Thomas, Hayden, Wesdyk, Russell, Windisch, Joerg, Vaithiyalingam, Sivakumar
Publicado no AAPS J (2015)

Advancing Product Quality: a Summary of the Second FDA/PQRI Conference

Por Yu, Lawrence X., Akseli, Ilgaz, Allen, Barbara, Amidon, Gregory, Bizjak, Tara Gooen, Boam, Ashley, Caulk, Margaret, Doleski, David, Famulare, Joseph, Fisher, Adam C., Furness, Scott, Hasselbalch, Brian, Havel, Henry, Hoag, Stephen W., Iser, Robert, Johnson, Bruce D., Ju, Robert, Katz, Paula, Lacana, Emanuela, Lee, Sau L., Lostritto, Richard, McNally, Grace, Mehta, Mehul, Mohan, Ganapathy, Nasr, Moheb, Nosal, Roger, Oates, Mary, O’Connor, Thomas, Polli, Jim, Raju, G. K., Ramanadham, Mahesh, Randazzo, Giuseppe, Rosencrance, Susan, Schwendeman, Anna, Selen, Arzu, Seo, Paul, Shah, Vinod, Sood, Ramesh, Thien, Michael P., Tong, Tony, Trout, Bernhardt L., Tyner, Katherine, Vaithiyalingam, Siva, VanTrieste, Martin, Walsh, Fionnuala, Wesdyk, Russell, Woodcock, Janet, Wu, Geoffrey, Wu, Larisa, Yu, Louis, Zezza, Diane
Publicado no AAPS J (2016)