GDUFA Research Outcomes
QbD for Generics
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to manufacturing and quality by design for generic products.
-
Quality by Design: Concepts for ANDAs
Lionberger, Robert; Lee, Sau; Lee, Laiming; Raw, Andre; Yu, Lawrence
-
Quality by Design for Generic Drugs
Yu, Lawrence; Lionberger, Robert; Olson, Michael; Johnston, Gordon; Buehler, Gary; Winkle, Helen
-
Using Control Charts to Evaluate Pharmaceutical Manufacturing Process Variability
Peng, Daniel; Lionberger, Robert; Viehmann, Alex; Iyer, Karthik; Yu, Lawrence
-
Completeness Assessment of Type II Active Pharmaceutical Ingredient Drug Master Files under Generic Drug User Fee Amendment: Review Metrics and Common Incomplete Items
Zhang, Huyi; Li, Haitao; Song, Wei; Shen, Diandian; Skanchy, David; Shen, Kun; Lionberger, Robert; Rosencrance, Susan; Yu, Lawrence
-
Using Process Capability to Ensure Pharamceutical Quality
Yu, Lawrence; Peng, Daniel; Lionberger, Robert; Viehmann, Alex; Iyer, Karthik
-
U.S. FDA Question-Based Review for Generic Drugs: A New Pharmaceutical Quality Assessment System
Yu, Lawrence; Raw, Andre; Lionberger, Robert; Rajagopalan, Radhika; Lee, Laiming; Holcombe, Frank; Patel, Rashmikant; Fang, Florence; Sayeed, Vilayat; Schwartz, Paul; Adams, Richard; Buehler, Gary
-
Applications of Process Analytical Technology to Crystallization Processes
Yu, Lawrence; Lionberger, Robert; Raw, Andre; D’costa, Rosario; Wu, Huiquan; Hussain, Ajaz