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

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