1. L.R. Snyder, J.L. Glajch, Computer-assisted Method Development for High-performance Liquid Chromatography, Elsevier, Amsterdam, 1990 (also J. Chromatogr. 485 (1989)).
2. ICH Q8 – Guidance for Industry, Pharmaceutical Development, 2006.
3. ICH Q9 – Quality Risk Management, 2006.
4. ICH Q10 – Pharmaceutical Quality System, 2009.
5. M. Nasr, CDER, FDA, Lecture on “Quality by Design (QbD): Analytical Aspects” at HPLC 2009, Dresden, Germany, September 2009.