Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 2: Safety Considerations of Impurities in...

Por Alsante, Karen M., Huynh-Ba, Kim C., Baertschi, Steven W., Reed, Robert A., Landis, Margaret S., Furness, Scott, Olsen, Bernard, Mowery, Mark, Russo, Karen, Iser, Robert, Stephenson, Gregory A., Jansen, Patrick
Publicado em 2013

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)