1. U.S. Food and Drug Administration, Title 21 Code of Federal Regulations (CFR) Part 320.25(f), Office of Federal Register, National Archives and Records Administration, U.S. Government Printing Office, Washington, DC, 2009.
2. Electronic Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of Generic Drugs. Current through January 2010.
http://www.fda.gov/cder/ob/default.htm
. Accessed 26 Feb 2010.
3. U.S. Food and Drug Administration, Title 21 Code of Federal Regulations (CFR) Part 320.1, Office of Federal Register, National Archives and Records Administration, U.S. Government Printing Office, Washington, DC, 2009.
4. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Waiver of in vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. August 2000.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070246.pdf
. Accessed 26 Feb 2010.
5. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Center for Biologics Evaluation and Research. Guidance for Industry: Q8(R2) Pharmaceutical Development. November 2009.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073507.pdf
. Accessed 26 Feb 2010.