GDUFA Research Outcomes

QbD for Generics

• All(7)
• Posters(0)
• Presentations(0)
• Papers(7)

• 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