Susan Cook is a scientist I, Katherine A. Patton is a scientist I, and L. Rochelle Bazemore, PhD, is a staff scientist, all at Diosynth Biotechnology, NC, 919.388.5700, susan.cook@diosynth-RTP.com
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1. Juran J. Quality by Design. Mankato, MN: The Free Press; 1992.
2. US Food and Drug Administration. Guidance for industry: Q8 pharmaceutical development. Rockville, MD; 2006 May.
3. US FDA. Guidance for Industry: PAT—a framework for innovative pharmaceutical development, manufacturing, and quality assurance.
Rockville, MD; 2004 Sept.
4. The PAT Team and Manufacturing Science Working Group. Innovation and continuous improvement in pharmaceutical manufacturing—Pharmaceutical
cGMPs for the 21st century. Rockville, MD; Aug 2002.
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