Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products: Workshop Summary Report

Por Chen, Mei-Ling, Shah, Vinod P., Ganes, Derek, Midha, Kamal K., Caro, James, Nambiar, Prabu, Rocci, Mario L., Thombre, Avinash G., Abrahamsson, Bertil, Conner, Dale, Davit, Barbara, Fackler, Paul, Farrell, Colm, Gupta, Suneel, Katz, Russell, Mehta, Mehul, Preskorn, Sheldon H., Sanderink, Gerard, Stavchansky, Salomon, Temple, Robert, Wang, Yaning, Winkle, Helen, Yu, Lawrence
Publicado em 2010

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 em 2014