Bioequvalence |



Two pharmaceutical products are bioequivalent if they are pharmaceutically equivalent and their bioavailabilities (rate and extent of availability) after administration in the same molar dose are similar to such a degree that their effects, with respect to both efficacy and safety, can be expected to be essentially the same.

Therapeutic equivalence might be based on demonstration of equivalent drug distribution in vitro, combined with bioequivalence based on pharmacokinetic data and/or pharmacodynamic data.

A successful therapeutic equivalence study requires demonstration of a significant dose-response relationship with the study of at least two doses of the test compared with, if possible, two doses of the reference product. Two products will be considered as equivalent if the following criteria are completely fulfilled:


Efficacy: If the relative potency approach is used the 95% confidence interval for the primary endpoint must be contained entirely within 80 – 125 %.

Safety: If possible bioequivalence in respect of systemic exposure should be demonstrated (the 90% confidence interval must be contained entirely within 80 – 125%).
Professor Hans Bisgaard • Copenhagen • Denmark •