Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products: Current Challenges and Future Prospects

Abstract

This chapter provides a critical overview of the presentations and discussions of a recent workshop “Evaluation of Topical Drug Products—Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies” which brought together pharmaceutical scientists and dermatologists from academia, industry, and regulatory agencies to discuss current regulatory issues and industry practices for establishing bioequivalence (BE) of dermatologic topical products. The methods currently available for assessment of BE were reviewed as well as alternatives and the advantages and disadvantages of each method were considered. The outcome of the workshop reviewed the current evaluation procedures of semisolid products and maintaining quality throughout the shelf-life. The workshop identified gaps in evaluation and approval of some semisolid products. The discussions pointed to the need for developing a “toolkit” approach toward solving the problem of determination of bioavailability and BE. Even some of the current accepted BE testing procedures may be so variable which will not allow effective development of some new generic products. It was concluded that there is a need for creative methods to allow development of generic products and assure access to safe and less-costly medications.