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 AAPS PharmSciTech（2014）
Key words
CMC,ICH,IVIVC,PAT,QbD
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