233 A novel ex vivo skin culture device enables clinically representative skin testing

Dermatology has the poorest rate of successful bench-to-clinic transitions. In part this is due to safety testing being historically performed on unrepresentative animal models, or replacement tests that use animal, rather than human data as benchmark for efficacy. As a result, preclinical models are unable faithfully replicate responses. Here, we examined whether novel environmentally relevant skin culture device able better mimic responses permeation and irritation. We engineered biphasic fluidic combining regulation atmospheric air, humidity, temperature, pH media flow, replicating physiological environment skin. Using device, assessed caffeine ibuprofen in ex vivo at baseline cultured five days found no significant difference absorption profiles (p 0.05 ANOVA with Dunnet’s multiple comparisons test). Additionally, irritation potential compounds, developing methodology based approved OECD 439 test. Approved validation chemicals, compounds incorrectly categorised were assessed. The chemicals correctly (100% accuracy), results fully replicated published clinical data. conclusion, physiologically was essential maintaining function clinically examples, demonstrate should replace traditional methods development accurate, human-representative analysis confident