Determining bioequivalence of topical dermatological drug products by tape-stripping

Journal of Pharmacokinetics and Pharmacodynamics

Volumn 35, Issue 3, 2008, Pages 337-348

  Navidi, William ^a   Hutchinson, Ashlyn ^a   N'Dri Stempfer, Berthe ^a   Bunge, Annette ^a  

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

Author keywords

Bioequivalence; Efficiency; Tape stripping; Topical drugs

Indexed keywords

DERMATOLOGICAL AGENT; ECONAZOLE; RETINOIC ACID; RETINOL;

ACCURACY; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CALCULATION; DRUG ABSORPTION; DRUG CLEARANCE; DRUG TISSUE LEVEL; DRUG UPTAKE; HUMAN; INTERMETHOD COMPARISON; MATHEMATICAL ANALYSIS; MEASUREMENT; PERFORMANCE; PRIORITY JOURNAL; SIMULATION; STRATUM CORNEUM; STUDENT T TEST; TAPE STRIPPING METHOD; TWO TIME METHOD;

ALGORITHMS; AREA UNDER CURVE; CHEMISTRY, PHARMACEUTICAL; COMPUTER SIMULATION; DATA INTERPRETATION, STATISTICAL; DERMATOLOGIC AGENTS; HUMANS; MODELS, STATISTICAL; SKIN ABSORPTION; THERAPEUTIC EQUIVALENCY;

EID: 47149114761     PISSN: 1567567X     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10928-008-9091-7     Document Type: Article

References (11)

1. FDA (2007) Approved drug products with therapeutic equivalence evaluations (electronic orange book), 27th edn. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of Generic Drugs
2. Schoenwald R (2001) Pharmacokinetic principles of dosing adjustments: understanding the basics. CRC Press, Boca Raton, Florida
3. FDA (1988) Guidance for industry: topical dermatological drug product ndas and andas-in vivo bioavailability, bioequivalence, in vitro release, and associated studies. Draft guidance, June 1988. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER)
4. Pershing LK (2000) Final report to food and drug administration (FDA): dermatopharmacokinetic bioequivalence study on three tretinoin gel, 0.025% products. University of Utah, Salt Lake City
5. Pershing LK (2001) Bioequivalence assessment of three 0.025% tretinoin gel products: dermatopharmacokinetic vs. clinical trial methods. Presentation, advisory committee for pharmaceutical sciences meeting, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Rockville, MD, 29 November 2001
6. Pershing LK, Corlett JL, Nelson JL (2002) Comparison of dermatopharmacokinetic vs. clinical efficacy methods for bioequivalence assessment of miconazole nitrate vaginal cream, 2% in humans. Pharm Res 19: 270-277
7. Bunge A, N'Dri-Stempfer B, Navidi W, Guy R (2007) Final report to food and drug administration (FDA): therapeutic equivalence of topical products, Colorado School of Mines, Golden, Colorado. Available upon request: email abunge@mines.edu
8. N'Dri-Stempfer B, Guy R, Navidi W, Bunge A (2008) Improving dermatopharmacokinetic bioequivalence assessment of topical dermatological products, in preparation
9. Schuirmann D (1987) A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmaokinet Biopharm 15: 657-680
10. Herkenne C, Naik A, Kalia YN, Hadgraft J, Guy RH (2006) Pig ear skin ex vivo as a model for in vivo dermatopharmacokinetic studies in man. Pharm Res 23: 1850-1856
11. Pershing L, Nelson J, Corlett J, Shrivastava S, Hare D, Shah V (2003) Assessment of dermatopharmacokinetic approach in the bioequivalence determination of topical tretinoin gel products. J Am Acad Dermatol 48: 740-751