- Guideline On The Requirements To The Chemical And Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products In Clinical Trials CHMP/QWP/185401/2004, 1 October. 2006.
Topic Q8 Annex Pharmaceutical Development EMEA/CHMP/ICH/518819/2007, Draft November 2007, deadline for comments May 2008 http://www.emea.europa.eu/
- CBER Guidelines http://www.fda.gov/cber/guidelines.htm
- ICH Q7, Q8, Q9, Q10 http://www.ich.org/