Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products

Avraham Yacobi, Vinod P. Shah, Edward D. Bashaw, Eva Benfeldt, Barbara Davit, Derek Ganes, Tapash Ghosh, Isadore Kanfer, Gerald B. Kasting, Lindsey Katz, Robert Lionberger, Guang Wei Lu, Howard I. Maibach, Lynn K. Pershing, Russell J. Rackley, Andre Raw, Chinmay G. Shukla, Kailas Thakker, Nathalie Wagner, Elizabeta Zovko, Majella E. Lane

This paper summarises the proceedings of a recent workshop which brought together pharmaceutical scientists and dermatologists from academia, industry and regulatory agencies to discuss current regulatory issues and industry practices for establishing therapeutic 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. Guidance on quality and performance of topical products was reviewed and a framework to categorise existing and alternative methods for evaluation of BE was discussed. The outcome of the workshop emphasized both a need for greater attention to quality, possibly, via a Quality-By-Design (QBD) approach and a need to develop a "whole toolkit" approach towards the problem of determination of rate and extent in the assessment of topical bioavailability. The discussion on the BE and clinical equivalence of topical products revealed considerable concerns about the variability present in the current methodologies utilized by the industry and regulatory agencies. It was proposed that academicians, researchers, the pharmaceutical industry and regulators work together to evaluate and validate alternative methods that are based on both the underlying science and are adapted to the drug product itself instead of single "universal" method.