Bioequivalence

In contrast to systemically available medications, there are very few possibilities for proving the bioequivalence of topically applied medications without a clinical study on patients.

An important exception in this case are the corticosteroids. For these, we offer the vasoconstriction test in accordance with FDA and EMEA guidance. Because of its comprehensive experience in conducting this test, proDERM already has a prescreened panel of “responders”.

For other substances, it is increasingly possible to demonstrate bioequivalence by dermatopharmacokinetic parameters using Raman spectroscopy.