1. Multisource (generic) pharmaceutical products: Guidelines on registration requirements to establish interchangeability. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fortieth report, Geneva, World Health Organization, 2006 (WHO Technical Report Series number 937). Annex 7:347–390
2. Shargel L. Drug product performance and interchangeability of multisource drug substances and drug products. Pharmacopeial Forum. 2009;35:744–9.
3. 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 6 Jan. 2011
4. European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Guideline on the Investigation of Bioequivalence. London. January 20, 2010.
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf
. Accessed 20 Apr. 2011
5. European Agency for the Evaluation of Medicinal Products, Committee for Medicinal Products for Human Use (CHMP). Note for Guidance on Modified Release Oral and Transdermal Dosage Forms: Section II (Pharmacokinetic and Clinical Evaluation). July 1999