1. AAPS Workshop (2005). Pharmaceutical quality assessment—a science and risk-based CMC approach in the 21st century. October 5–7, North Bethesda, MD, USA
2. AAPS Workshop (2009). Utilization of process modeling and advanced process control in QbD based drug development and manufacturing. April 27–28, Baltimore, MD, USA
3. GPhA/FDA (2011) quality by design workshop for ANDAs. May 5–6, North Bethesda, MD, USA
4. Lionberger R, Lee S, Raw A, Yu L. Quality by design: concepts for ANDAs. AAPS J. 2008;10(2):268–76.
5. Yu L. Pharmaceutical quality by design: product and process development, understanding, and control. Pharm Research. 2008;25(3):781–91.