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

✍ Scribed by 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

• Book ID: 121536336
• Publisher: Springer US
• Year: 2014
• Tongue: English
• Weight: 733 KB
• Volume: 15
• Category: Article
• ISSN: 1530-9932
• DOI: 10.1208/s12249-014-0087-x