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
Titel:
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
Auteur:
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