Current Challenges in Bioequivalence,Quality, and Novel Assessment Technologies for Topical Products |
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Authors: | 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 |
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Institution: | 1. DOLE Pharma LLC, New York, New York, USA 2. Pharmaceutical Consultant, North Potomac, Maryland, USA 3. U.S. Food and Drug Administration, Silver Spring, Maryland, USA 4. Department of Dermatology, University of Copenhagen Roskilde Hospital, Copenhagen, Denmark 5. Ganes Pharma Inc., Toronto, Ontario, Canada 6. Rhodes University, Grahamstown, South Africa 7. University of Cincinnati, Cincinnati, Ohio, USA 8. Biostudy Solutions LLC, Wilmington, North Carolina, 28405, USA 9. Allergan, Irvine, California, USA 10. University of California–San Francisco, San Francisco, California, USA 11. University of Utah Health Sciences Center, Salt Lake City, Utah, USA 12. Mylan Pharmaceuticals Inc, Morgantown, West Virginia, USA 13. Tergus Pharma LLC, Durham, North Carolina, USA 14. Galderma R&D, Sophia Antipolis, France 15. Forest Research Institute, New York, USA 16. University College London School of Pharmacy, London, UK
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Abstract: | 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. |
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