Editing Bioequivalence (section)

=== Europe ===

According to regulations applicable in the [[European Economic Area]]<ref name="urlwww.emea.europa.eu">{{cite web | url = http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf | title = Guideline on the Investigation of Bioequivalence | author = Committee for Medicinal Products for Human Use |date=20 January 2010 | publisher = [[European Medicines Agency]] | access-date = 21 April 2011}}</ref> two medicinal products are bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives and if their bioavailabilities after administration in the same molar dose are similar to such a degree that their effects, with respect to both efficacy and safety, will be essentially the same. This is considered demonstrated if the 90% [[confidence interval]]s (90% CI) of the ratios for AUC<sub>0–t</sub> and ''C''<sub>max</sub> between the two preparations lie in the range 80–125%.