1. U.S. Food and Drug Administration, Center for Drug Evaluationand Research (CDER). Guidance for Industry: Bioavailability and BioequivalenceStudies for Orally Administered Drug Products—General Considerations,March (2003; Division of Drug Information Branch, HFD-240,Center for Drug Evaluation and Research, FDA:Rockville, MD;http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070124.pdf.
2. European Medicines Agency (EMEA) Committeefor MedicinalProducts for Human Use. Guideline on the Investigation of Bioequivalence;Doc.Ref.: CPMP/EWP/QWP/1401/98Rev.1/Corr; EMEA:London, January 20, 2010; http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf.
3. Summary Workshop Report: Bioequivalence, Biopharmaceutics Classification System, and Beyond
4. The BCS, BDDCS, and Regulatory Guidances