1. J. Woodcock. The concept of pharmaceutical quality. Am. Pharm. Rev. Nov/Dec 2004:pp. 1–3.
2. M. N. Nasr. Implementation of quality by design (QbD): status, challenges, and next steps. FDA Advisory Committee for Pharmaceutical Science. Available at: http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4241s1_6.ppt (accessed 11/21/2007).
3. L. X. Yu. Implementation of quality-by-design: OGD initiatives. FDA Advisory Committee for Pharmaceutical Science. Available at: http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4241s1_8.ppt (accessed 11/21/2007).
4. ISPE PQLI. Draft PQLI summary update report. http://www.ispe.org/cs/pqli_product_quality_lifeycle_implementation_/draft_pqli_summary_update_report (accessed 11/21/2007).
5. W. P. Ganzer, J. A. Materna, M. B. Mitchell, and L. K. Wall. Current thoughts on critical process parameters and API synthesis. Pharm. Technology. 46–66 (2005), July.