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

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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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ACKNOWLEDGMENTS AND DISCLOSURES

The views expressed here are the views of the scientists and do not represent the policy of their respective agencies or organization.

The Product Quality Research Institute (PQRI) is a non-profit consortium of organizations working together to generate and share timely, relevant, and impactful information that advances drug product quality and development.

By virtue of its diverse membership, PQRI provides a unique forum to focus critical thinking, conduct research, exchange information, and propose methodology or guidance to pharmaceutical companies, regulators, and standard setting organizations.

Author information

Authors and Affiliations

  1. DOLE Pharma LLC, New York, New York, USA

    Avraham Yacobi

  2. Pharmaceutical Consultant, North Potomac, Maryland, USA

    Vinod P. Shah

  3. U.S. Food and Drug Administration, Silver Spring, Maryland, USA

    Edward D. Bashaw, Barbara Davit, Tapash Ghosh, Robert Lionberger, Andre Raw & Chinmay G. Shukla

  4. Department of Dermatology, University of Copenhagen Roskilde Hospital, Copenhagen, Denmark

    Eva Benfeldt

  5. Ganes Pharma Inc., Toronto, Ontario, Canada

    Derek Ganes

  6. Rhodes University, Grahamstown, South Africa

    Isadore Kanfer

  7. University of Cincinnati, Cincinnati, Ohio, USA

    Gerald B. Kasting

  8. Biostudy Solutions LLC, Wilmington, North Carolina, 28405, USA

    Lindsey Katz

  9. Allergan, Irvine, California, USA

    Guang Wei Lu

  10. University of California–San Francisco, San Francisco, California, USA

    Howard I. Maibach

  11. University of Utah Health Sciences Center, Salt Lake City, Utah, USA

    Lynn K. Pershing

  12. Mylan Pharmaceuticals Inc, Morgantown, West Virginia, USA

    Russell J. Rackley

  13. Tergus Pharma LLC, Durham, North Carolina, USA

    Kailas Thakker

  14. Galderma R&D, Sophia Antipolis, France

    Nathalie Wagner

  15. Forest Research Institute, New York, USA

    Elizabeta Zovko

  16. University College London School of Pharmacy, London, UK

    Majella E. Lane

Authors
  1. Avraham Yacobi
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  2. Vinod P. Shah
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  3. Edward D. Bashaw
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  4. Eva Benfeldt
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  5. Barbara Davit
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  6. Derek Ganes
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  7. Tapash Ghosh
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  8. Isadore Kanfer
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  9. Gerald B. Kasting
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  10. Lindsey Katz
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  11. Robert Lionberger
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  12. Guang Wei Lu
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  13. Howard I. Maibach
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  14. Lynn K. Pershing
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  15. Russell J. Rackley
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  16. Andre Raw
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  17. Chinmay G. Shukla
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  18. Kailas Thakker
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  19. Nathalie Wagner
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  20. Elizabeta Zovko
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  21. Majella E. Lane
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Corresponding author

Correspondence to Majella E. Lane.

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Yacobi, A., Shah, V.P., Bashaw, E.D. et al. Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products. Pharm Res 31, 837–846 (2014). https://doi.org/10.1007/s11095-013-1259-1

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  • DOI: https://doi.org/10.1007/s11095-013-1259-1

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