1. FDA http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm088828.htm 2008
2. FDA http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073507.pdf 2009
3. A. Brindle European Pharmaceutical Review Industry Focus 2008 54 55 2008