1. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products–General Considerations, Office of Training and Communications, Division of Communications Management, Drug Information Branch, HFD-210, Rockville MD 20857, March 2003
2. U.S. Food and Drug Administration: Statistical approaches to establishing bioequivalence. Guidance for industry. Office of Training and Communications, Division of Communications Management, Drug Information Branch, HFD-210, Rockville MD 20857, January 2001
3. EMEA/CPMP/EWP/1401/98. Note for guidance on the investigation of bioavailability and bioequivalence. EMEA, London, 26 July 2001. http://www.emea.europa.eu/pdfs/human/qwp/140198enfin.pdf
4. EMEA/CHMP/EWP/200943/2007. Recommendation on the need for revision of (CHMP) “Note for guidance on the investigation of bioavailability and bioequivalence” CPMP/EWP/QWP/1401/98. http://www.emea.europa.eu/pdfs/human/ewp/20094307en.pdf
5. U.S. Food and Drug Administration: Bioequivalence Requirements for Highly Variable Drugs and Drug Products. Background Information for Advisory Committee Meeting, On April 11, 2004