online seminar: In-vitro performance testing for topically applied formulations

Summary

In order to be effective, topically applied drugs need to overcome at least the outermost layer of the skin. The skin is a complex and efficient barrier with various factors that can influence penetration. Paradigms of dermal bioavailability are different and at least partially less straightforward than in peroral drug delivery. And, there is not the single in vitro model that fits all purposes. Nevertheless, in vitro performance testing of topicals can be performed in a systematic manner. It is an important aspect of early projects for compound and formulation selection and overall program de-risking, and can support toxicological characterization. Most importantly, it is used to establish bioequivalence in generic development programs and post-approval changes. For this purpose, the respective regulatory guidelines must be taken into account.