Certified dOFM sampling devices provide access to target tissue in pharmaceutical trials

Abstract

Clinical testing of dermatological drugs re-quires access to the site of drug action within the dermis. Conventional methods such as skin biopsies are rather invasive and provide limited data on the kinetics and dynamics of drugs. We present minimally invasive dermal sampling probes and a wearable pump for continuous sampling from the dermis. These dermal open flow mi-croperfusion (dOFM) devices comply with international medical device guidelines (CE certified) and have demon-strated applicability and tolerability in clinical trials. dOFM is likely to become an invaluable tool for clinical bioequivalence trials prior to market release of generic drugs.