Dermal open flow microperfusion for PK-based clinical bioequivalence studies of topical drug products

Topically applied drug products have experienced an extraordinary price increase in the United States, mostly due to a lack of generic products. Generic drug development is hindered by high costs and risks associated with clinical endpoint studies required to show bioequivalence (BE) of prospective generic products relative to their reference products. There is a continued need for cost- and time-efficient alternatives to clinical endpoint studies to determine BE of topically applied dermal drug products. Cutaneous PK-based BE studies present such an alternative and dOFM (dermal open flow microperfusion) has already been successfully used in several verifications studies to show an accurate and sensitive assessment of the rate and extent at which drugs become available in the skin. dOFM technology is discussed as well as the dOFM setup of clinical pilot and main studies to achieve BE assessment with a minimum number of participants and an outlook is given on the use of dOFM technology for other drug products.

Automated summary

Topically applied drug products in the US have seen significant price increases due to a lack of generic options. Generic drug development is limited by high costs and risks associated with proving bioequivalence. Cutaneous PK-based studies offer a cost-effective alternative to clinical endpoint studies.