1. Quality by design: concepts for ANDAs;Lionberger;The AAPS Journal,2008
2. USFDA Pharmaceutical CGMPs for the 21st century - A risk-based approach, Final Report , United States Department of Health and Human Services, US Food and Drug Administration, September 2004 http://www.fda.gov/oc/cgmp/report0507 .html
3. USFDA CDER United States Department of Health and Human Services US Food and Drug Administration 2004