1. FDA 21CFR320.1 PART 320 - Bioavailability and Bioequivalence requirements 2000
2. Directive 2004/27/EC of the European Parliament and the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use Official Journal L - 136, 30/04/2004 34 - 57
3. 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 2003
4. EMEA/CPMP/EWP/1401/98. Note for guidance on the investigation of bioavailability and bioequivalence 2001
5. Pan American Health Organization. Regional Office of the World Health Organization Science based criteria for bioequivalence in vivo and in vitro , bio-waivers, and strategic framework for implementation http://www.paho.org/english/ad/ths/ev/be-doct-draft-eng.pdf