1. The concept of pharmaceutical quality;Woodcock;Am. Pharm. Rev.,2004
2. Q9: Quality Risk Management. ICH Harmonized Tripartite Guidelines International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use,2006
3. Q10: Pharmaceutical Quality System, ICH Tripartite Guidelines. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use,2007
4. Quality by design: concepts for ANDAs;Lionberger;AAPS J.,2008
5. Juran on Quality by Design: The New Steps for Planning Quality Into Goods and Services;Juran,1992