1. The current EU legal definition for generic products is found in Directive 2001/83/EC, Article 10 (2)(b)
2. Chow S-C, Liu J-P (1992) Design and Analysis of Bioavailability and Bioequivalence Studies. Marcel Dekker Inc., New York
3. Guideline on the investigation of bioequivalence, CHMP/EWP/QWP/1401/98 Rev. 1,29 January 2010
4. Endrenyi L, Yan W (1993) Variation of Cmax and Cmax/AUC in investigations of bioequivalence. Int J Clin Pharmacol Therapy Toxicol 31(4): 184–189
5. The same criteria also apply in the USA and in many other countries worldwide.