FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications

بواسطة Yu, Lawrence X., Raw, Andre, Wu, Larisa, Capacci-Daniel, Christina, Zhang, Ying, Rosencrance, Susan
الحاوية / القاعدة Int J Pharm X (2019)

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

بواسطة Zhang, Huyi, Li, Haitao, Song, Wei, Shen, Diandian, Skanchy, David, Shen, Kun, Lionberger, Robert A., Rosencrance, Susan M., Yu, Lawrence X.
منشور في 2014

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

بواسطة 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
الحاوية / القاعدة AAPS J (2015)

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

بواسطة 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
الحاوية / القاعدة AAPS J (2016)