Optimizing metrics for the assessment of bioequivalence between topical drug products

Pharmaceutical Research

Volumn 25, Issue 7, 2008, Pages 1621-1630

  N'Dri Stempfer, Berthe ^a   Navidi, William C ^a   Guy, Richard H ^b   Bunge, Annette L ^a  

^a Department of Geology and Geological Engineering   (United States)

^b UNIVERSITY OF BATH   (United Kingdom)

Author keywords

Dermatopharmacokinetics; Skin; Stratum corneum; Tape stripping; Topical drug bioequivalence

Indexed keywords

ISOTRETINOIN; RETINOIC ACID;

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; DATA ANALYSIS; DRUG CLEARANCE; DRUG DOSAGE FORM; DRUG HALF LIFE; DRUG PENETRATION; DRUG UPTAKE; GEL; HUMAN; PRIORITY JOURNAL; SKIN PENETRATION; STRATUM CORNEUM; TOPICAL DRUG ADMINISTRATION;

ADMINISTRATION, TOPICAL; ALGORITHMS; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; GELS; HALF-LIFE; RETINOIDS; SKIN ABSORPTION; THERAPEUTIC EQUIVALENCY; TRETINOIN;

EID: 44749086444     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-008-9577-4     Document Type: Article

References (25)

1. V. P. Shah, G. L. Flynn, A. Yacobi, H. I. Maibach, C. Bon, N. M. Fleischer, T. J. Franz, S. A. Kaplan, J. Kawamoto, L. J. Lesko, J.-P. Marty, L. K. Pershing, H. Schaefer, J. A. Sequeira, S. P. Shrivastave, J. Wilkins, and R. L. Williams. Bioequivalence of topical dermatological dosage forms-methods of evaluation of bioequivalence. Pharm. Res. 15:167-171 (1998).
2. US FDA. Guidance for Industry: topical dermatological drug product NDAs and ANDAs-in vivo bioavilability, bioequivalence, in vitro release, and associated studies. Draft Guidance, June 1998, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 1998.
3. L. K. Pershing, J. L. Nelson, J. L. Corlett, S. P. Shrivastave, D. B. Hare, and V. P. Shah. Assessment of dermatopharmacokinetic approach in the bioequivalence determination of topical tretinoin gel products. J Am Acad Dermatol. 48:740-751 (2003).
4. L. K. Pershing. Final Report to Food and Drug Administration (FDA): Dermatopharmacokinetic Bioequivalence Study on Three Tretinoin Gel, 0.025% Products, University of Utah, Salt Lake City, 2000.
5. US FDA. Guidance for industry on special protocol assessment; availability. Fed. Reg. 67:35122 (2002).
6. A. L. Bunge, B. N'Dri-Stempfer, W. C. Navidi, and R. H. Guy. 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, Food and Drug Administration, Colorado School of Mines, Golden, CO, September 2, 2006.
7. A. L. Bunge, B. N'Dri-Stempfer, W. C. Navidi, and R. H. Guy. Therapeutic Equivalence of Topical Products, Final Report, Award No. 223-04-3004, Submitted to Department of Health and Human Services, Food and Drug Administration, Colorado School of Mines, Golden, CO, January 30, 2007.
8. L. K. Pershing. Bioequivalence Assessment of three 0.025% tretinoin gel products: Dermatopharmacokinetic vs. Clinical Trial Methods. Advisory Committee for Pharmaceutical Sciences Meeting, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Rockville, MD, 2001.
9. T. J. Franz. Study #1, Avita Gel 0.025% vs Retin-A Gel 0.025%, Advisory Committee for Pharmaceutical Sciences Meeting, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Rockville, MD, 2001.
10. D. P. Conner. Differences in DPK Methods. Advisory Committee for Pharmaceutical Sciences Meeting, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Rockville, MD, 2001. http://www.fda.gov/ ohrms/dockets/ac/01/slides/3804s2_05_conner/index.htm, pp 71-75 in transcript.
11. I. Alberti, Y. Kalia, A. Naik, J.-D. Bonny, and R. H. Guy. In vivo assessment of enhanced topical delivery of terbinafine to human stratum corneum. J Control. Release. 71:319-327 (2001).
12. I. Alberti, Y. N. Kalia, A. Naik, J. D. Bonny, and R. H. Guy. Assessment and prediction of the cutaneous bioavailability of topical terbinafine in vivo. Pharm. Res. 18:1472-1475 (2001).
13. I. Alberti, Y. N. Kalia, A. Naik, J.-D. Bonny, and R. H. Guy. Effect of ethanol and isopropyl myristate on the availability of topical terbinafine in human stratum corneum, in vivo. Int. J. Pharm 219:11-19 (2001).
14. F. Pirot, Y. N. Kalia, A. L. Stinchcomb, G. Keating, A. Bunge, and R. H. Guy. Characterization of the permeability barrier of human skin in vivo. Proc. Nat. Acad. Sci. USA. 94:1562-1567 (1997).
15. M. B. Reddy, A. L. Stinchcomb, R. H. Guy, and A. L. Bunge. Determining dermal absorption parameters in vivo from tape stripping data. Pharm. Res. 19:292-297 (2002).
16. R. J. Scheuplein, and I. H. Blank. Permeability of the skin. Physiol. Rev. 51:702-747 (1971).
17. M. S. Roberts, and K. A. Walters. The relationship between structure and barrier function of skin. In M. S. Roberts, and K. A. Walters (eds.), Dermal Absorption and Toxicity Assessment, Vol 91., Drugs and the Pharmaceutical Sciences, Marcel Dekker, New York, 1998, pp. 1-42.
18. J. Hadgraft. Skin, the final frontier. Int. J. Pharm. 224:1-18 (2001).
19. E. Kreyszig. Advanced Engineering Mathematics. 8th Edition, Wiley, New York, NY, 1999.
20. D. J. Schuirmann. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J. Pharmacokinet. Biopharm. 15:657-680 (1987).
21. US FDA. Avita Gel (Tretinoin Gel), NDA Application No.: 20-400. http://www.fda.gov/cder/foi/nda/98/20400.htm, 1998.
22. US FDA. Approved drug products with therapeutic equivalence evaluations (Electronic Orange Book), US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of Generic Drugs. http://www.fda.gov/cder/orange/ obannual.pdf, 2007.
23. L. K. Pershing, J. L. Corlett, and J. L. Nelson. Comparison of dermatopharmacokinetic vs. clinical efficacy methods for bioequivalence assessment of miconazole nitrate vaginal cream, 2% in humans. Pharm. Res. 19:270-277 (2002).
24. A. L. Bunge, R. L. Cleek, and B. E. Vecchia. A new method for estimating dermal absorption from chemical exposure. 3. Compared with steady-state methods for prediction and data analysis. Pharm. Res. 12:972-982 (1995).
25. R. L. Cleek, and A. L. Bunge. A new method for estimating dermal absorption from chemical exposure. 1. General approach. Pharm. Res. 10:497-506 (1993).