1. International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use,,2009
2. Guidance for industry PAT - Framework for innovative pharmaceutical development, manufacturing and quality assurance;US Food and Drug Administration,2004
3. International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use,2005
4. International International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use,2008