Bioavailability and Bioequivalence

Bioequivalence Studies

If two medicines are bioequivalent there is no clinically significant difference in their bioavailability. Although bioequivalence is most commonly discussed in relation to generic medicines, it is important to note that bioequivalence studies are also performed for innovator medicines in some situations such as: between early and late clinical trial formulations or between the formulations used in clinical trials and the product to be marketed for new medicines when changes in formulation have occurred after an innovator product has been approved, for example a change in one or more excipients (inactive ingredients)