The Pharmaceutical Sciences in 2020: Report of a Conference Organized by the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation (FIP)

por Shah, Vinod P., Besancon, Luc J. R., Stolk, Pieter, Tucker, Geoffrey, Crommelin, Daan J. A.
Publicado 2010

A pragmatic regulatory approach for complex generics through the U.S. FDA 505(j) or 505(b)(2) approval pathways

por Klein, Kevin, Borchard, Gerrit, Shah, Vinod P., Flühmann, Beat, McNeil, Scott E., de Vlieger, Jon S. B.
Publicado 2021

Tackling the challenges of nanomedicines: are we ready?

por Hertig, John B, Shah, Vinod P, Flühmann, Beat, Mühlebach, Stefan, Stemer, Gunar, Surugue, Jacqueline, Moss, Rob, Di Francesco, Tiziana
Publicado 2021

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ribavirin

por Goodarzi, Navid, Barazesh Morgani, Ahmadreza, Abrahamsson, Bertil, Cristofoletti, Rodrigo, Groot, D.W., Langguth, Peter, Mehta, Mehul U., Polli, James E., Shah, Vinod P., Dressman, Jennifer B.
Publicado 2016

Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: “Drug Products, Including Biological Products, that Contain Nanomaterials”

por de Vlieger, Jon S. B., Crommelin, Daan J. A., Tyner, Katherine, Drummond, Daryl C., Jiang, Wenlei, McNeil, Scott E., Neervannan, Sesha, Crist, Rachael M., Shah, Vinod P.
Publicado 2019

FIP/AAPS Joint Workshop Report: Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms

por Brown, Cynthia K., Friedel, Horst Dieter, Barker, Amy R., Buhse, Lucinda F., Keitel, Susanne, Cecil, Todd L., Kraemer, Johannes, Morris, J. Michael, Reppas, Christos, Stickelmeyer, Mary P., Yomota, Chikako, Shah, Vinod P.
Publicado 2011

Best Practices for the Development, Scale-up, and Post-approval Change Control of IR and MR Dosage Forms in the Current Quality-by-Design Paradigm

por Van Buskirk, Glenn A., Asotra, Satish, Balducci, Christopher, Basu, Prabir, DiDonato, Gerald, Dorantes, Angelica, Eickhoff, W. Mark, Ghosh, Tapash, González, Mario A., Henry, Theresa, Howard, Matthew, Kamm, Jason, Laurenz, Steven, MacKenzie, Ryan, Mannion, Richard, Noonan, Patrick K., Ocheltree, Terrance, Pai, Umesh, Poska, Richard P., Putnam, Michael L., Raghavan, Ramani R., Ruegger, Colleen, Sánchez, Eric, Shah, Vinod P., Shao, Zezhi Jesse, Somma, Russell, Tammara, Vijay, Thombre, Avinash G., Thompson, Bruce, Timko, Robert J., Upadrashta, Satyam, Vaithiyalingam, Sivakumar
Publicado 2014