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.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for industry. Bioavailability and bioequivalence studies for orally administered drug products-general considerations. 2003.
Code of Federal Regulations. Title 21 Part 320.24 (b) (1–4).
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm296733.pdf. Accessed 14 Nov 2014.
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm086293.pdf. Accessed 14 Nov 2014.
McKenzie AW, Stoughton RB. Method of comparing percutaneous absorption of steroids. Arch Dermatol. 1962;86:608–10.
Office of Generic Drugs, Center for Drug Evaluations and Research, FDA. Guidance: topical dermatologic corticosteroids: in vivo bioequivalence. 1995.
US FDA. Guidance for Industry: topical dermatological drug product NDAs and ANDAs-in vivo bioavailability, bioequivalence, in vitro release, and associated studies. Draft Guidance, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; June 1998.
US FDA. Guidance for industry on special protocol assessment; availability. Fed Regist. 2002;67:35122.
Pershing LK. Bioequivalence assessment of three 0.025 % tretinoin gel products: dermatopharmacokinetic vs. clinical trial methods, Transcribed presentation to the Advisory Committee for Pharmaceutical Sciences Meeting, Center for Drug Evaluation and Research, FDA; 2001 Nov 29; Rockville.
Franz TJ. Study #1, Avita Gel 0.025 % vs Retin-A Gel 0.025 %, Transcribed presentation, Advisory Committee for Pharmaceutical Sciences Meeting, Center for Drug Evaluation and Research, FDA; 2001 Nov 29; Rockville.
Bunge AL, N’Dri-Stempfer B, Navidi WC, Guy RH. Dermatopharmacokinetics: improvement of methodology for assessing bioequivalence of topical dermatological drug products, Revised Final Report, Award No. D3921303, Submitted to Department of Health and Human Services, FDA, Colorado School of Mines; 2006 Sept 2; Golden.
Bunge AL, N’Dri-Stempfer B, Navidi WC, Guy RH. Therapeutic Equivalence of Topical Products, Final Report, Award No. 223-04-3004, Submitted to Department of Health and Human Services, FDA, Colorado School of Mines; 2007 Jan 30; Golden (Revision submitted June 2008).
Petersen LJ, Kristensen JK, Bülow J. Microdialysis of the interstitial water space in human skin in vivo: quantitative measurement of cutaneous glucose concentrations. J Invest Dermatol. 1992;99:357–60.
Ortiz PG, Hansen SH, Shah VP, Menné T, Benfeldt E. The effect of irritant dermatitis on cutaneous bioavailability of a metronidazole formulation, investigated by microdialysis and dermatopharmacokinetic method. Contact Dermat. 2008;59:23–30.
Ortiz PG, Hansen SH, Shah VP, Menné T, Benfeldt E. Impact of adult atopic dermatitis on topical drug penetration: assessment by cutaneous microdialysis and tape stripping. Acta Derm Venereol. 2009;89:33–8.
Benfeldt E, Hansen SH, Vølund A, Menné T, Shah VP. Bioequivalence of topical formulations in humans: evaluation by dermal microdialysis sampling and the dermatopharmacokinetic method. J Invest Dermatol. 2007;127:170–8.
Bodenlenz M, Hoefferer C, Priedl J, Dragatin C, Korsatko S, Liebenberger L, Zahiragic S, Raml R, Magnes C, Pieber T, Sinner F. A novel certified dermal sampling system for efficient clinical research. J Invest Dermatol. 2011;131 (Suppl 2):S44–4.
Caspers PJ, Lucassen GW, Bruining HA, Puppels GJ. Automated depth-scanning confocal Raman microspectrometer for rapid in vivo determination of water concentration profiles in human skin. J Raman Spectrosc. 2000;31:813–8.
Mateus R, Abdalghafor H, Oliveira G, Hadgraft J, Lane ME. A new paradigm in dermatopharmacokinetics—confocal Raman spectroscopy. Int J Pharm. 2013;444:106–8.
OECD (2004) Test No. 428: skin absorption: in vitro method. OECD, p. 8.
Franz TJ, Lehman PA, Raney SG. Use of excised human skin to assess the bioequivalence of topical products. Skin Pharmacol Physiol. 2009;22:276–86.
FDA. SUPAC-SS nonsterile semisolid dosage forms, scale-up and postapproval changes: chemistry, manufacturing, and controls; in vitro release testing and in vivo bioequivalence documentation.U.S. Department of Health and Human Services, Washington, DC. 1997. http://www.fda.gov/cder/guidance/1447fnl.pdf. Accessed 09 April 2007.
Chang R-K, Raw A, Lionberger, Yu L. Generic development of topical dermatologic products: Formulation development, process development, and testing of topical dermatologic products. AAPS J. 2013;15:41–52.
Yacobi A, Shah VP, Bashaw ED, Benfeldt E, Davit B, Ganes D, Ghosh T, Kanfer I, Kasting GB, Katz L, Lionberger R, Lu GW, Maibach HI, Pershing LK, Rackley RJ, Raw A, Shukla CG, Thakker K, Wagner N, Zovko E, Lane ME. Current challenges in bioequivalence, quality, and novel assessment technologies for topical products. Pharm Res. 2014;31(4):837–46.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2014 Springer Science+Business Media New York
About this chapter
Cite this chapter
Shah, V., Yacobi, A., Lane, M. (2014). Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products: Current Challenges and Future Prospects. In: Shah, V., Maibach, H., Jenner, J. (eds) Topical Drug Bioavailability, Bioequivalence, and Penetration. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-1289-6_23
Download citation
DOI: https://doi.org/10.1007/978-1-4939-1289-6_23
Published:
Publisher Name: Springer, New York, NY
Print ISBN: 978-1-4939-1288-9
Online ISBN: 978-1-4939-1289-6
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)