Development of a model-based approach to assess bioequivalence based on dermatopharmacokinetic data obtained from comparative studies on topical dermatological drug products

Market approval of generic products requires that such products are shown to have equivalent safety and efficacy as the innovator product currently on the market. In general, generic topical dermatological products require comparative clinical trials in patients which require a large number of patients, are expensive and lengthy. This has led to a shortage of generic medicines that are meant to be applied to the skin. We developed a surrogate method to assess the safety and efficacy using tape stripping of human skin which is a relatively non-invasive technique. However, this method involves numerous determinations and is time-consuming. Hence, our objective is to develop a more efficient and expedient method using a model-based approach from which pharmacokinetic parameters relevant to assessment of a topical formulation can be deduced which will circumvent the need for numerous measurements and assumptions. Publication of the results will enhance the future prospects of the partner organization, Learn and Confirm Inc.

Seeprarani Rath
Faculty Supervisor: 
Isadore Kanfer
Partner University: