How to Demonstrate Virtual Bioequivalence for Complex Dermal Generic Drugs

The high cost of running clinical BE trials is a major challenge in developing generic versions of topical drugs. As a result, many branded topicals remain on the market past the originator’s patent expiration date, without the option of cost-effective generic alternatives that could benefit patients. In silico modeling & simulation, specifically mechanistic physiologically based pharmacokinetics (PBPK) that leverages in vitro data rather than running an in vivo comparative clinical BE endpoint study. Watch this webinar to learn how Certara expanded its PBPK Simcyp Simulator to incorporate an extensive dermal model— MPML MechDermA. This multi-phase, multi-dimensional dermal absorption model is based on detailed description of skin physiology. The model can simulate drug partitioning and absorption through the hair follicular pathway with blood flow to the dermis modeled as a function of cardiac output, body weight, and body surface area. It also accounts for drug formulation components specific to solutions, emulsions, patches, suspensions, and pastes. VBE leverages advanced modeling and simulation to demonstrate BE and provide additional insight into drug performance. These in silico studies are safer, faster, and less expensive to conduct than clinical BE studies and represent an important advance for generic and innovator drug companies alike.



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