Abstract

The assessment of the bioequivalence (BE) of topical dermatological formulations is a long standing challenge. There are only a limited number of acceptable methods for determining BE between the generic topical dermatological products and reference list products. To establish the BE of most topical dermatological products, barring dermatological corticosteroids, the only method to-date has been to undertake tedious, time consuming and expensive clinical endpoint trials. Therefore, significant efforts are being made to find alternative approaches for BE assessment of topical dermatological formulations. The pharmaceutical scientists, dermatologists and regulatory agencies are considering promising surrogate approaches like derma to pharmacokinetic study (DPK), dermal micro dialysis (DMD) and in vitro studies as prospective strategies for establishing BE of topical dermatological products. This short review focuses on these potential surrogate approaches for demonstration of BE of generic topical dermatological products with an emphasis on their strengths and limitations.