The cadaver skin absorption model and the drug development process

Pharmacopeial Forum

Volumn 34, Issue 5, 2008, Pages 1349-1356

  Franz, Thomas J ^a,b   Lehman, Paul A ^a   Raney, Sam G ^a  

^a PRACS Instituto Ltd

^b UNITED STATES PHARMACOPEIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALCLOMETASONE; BETAMETHASONE VALERATE; CORTICOSTEROID; DIFLORASONE DIACETATE; EFLORNITHINE; EPHEDRINE; ESTRADIOL; FLUOCINONIDE; GENERIC DRUG; GLUCOCORTICOID; KETOCONAZOLE; MOMETASONE FUROATE; RETINOIC ACID; SCOPOLAMINE; TESTOSTERONE; ULOBETASOL PROPIONATE;

ACNE VULGARIS; ARTICLE; BIOEQUIVALENCE; CADAVER; CREAM; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG DELIVERY SYSTEM; DRUG DOSAGE FORM COMPARISON; DRUG FORMULATION; DRUG MANUFACTURE; DRUG PENETRATION; FOAM; HUMAN; IN VITRO STUDY; NONHUMAN; OINTMENT; SKIN ABSORPTION; TIME TO MAXIMUM PLASMA CONCENTRATION;

EID: 53349109910     PISSN: 03634655     EISSN: 15421945     Source Type: Journal    
DOI: None     Document Type: Article

References (24)

1. McKenzie AW, Stoughton RB. Method of comparing percutaneous absorption of steroids. Arch Dermatol. 1962;86:608-610.
2. FDA, CDER. Guidance: topical dermatologic corticosteroids: in vivo bioequivalence. (1995). Available at: http://www.fda.gov/ohrms/dockets/ dockets/04p0206/ 04p-0206-ref0001-08-FDA-Guidance-for-Industry-06-1995-vol3.pdf. Accessed 18 March 2008.
3. Fritsch WC, Stoughton RB. The effect of temperature and humidity on the penetration of C14-acetylsalicylic acid in excised human skin. J Invest Dermatol. 1963;41:307-310.
4. Coldman WD, Poulsen BJ, Higuchi T. Enhancement of percutaneous absorption by the use of volatile:non-volatile systems as vehicles. J Pharm Sci. 1969;58:1098-1102.
5. Franz TJ. Percutaneous absorption. On the relevance of in vitro data. J Invest Dermatol. 1975;64:190-195.
6. Franz TJ. The finite dose technique as a valid in vitro model for the study of percutaneous absorption in man. In: Simon G, Paster Z, Klingberg M, Kaye M, eds. Skin: Drug Application and Evaluation of Environmental Hazards, Current Problems in Dermatology. Basel, Switzerland: S. Karger; 1978:58N68.
7. Sulzberger MB, Witten VH, Smith CC. Hydrocortisone (Compound F) acetate ointment in dermatologic therapy. JAMA. 1953;151:468-472.
8. Witten VH. History. In: Maibach HI, Surber C, eds. Topical Corticosteroids. Basel, Switzerland: Karger; 1992:1-5.
9. Stoughton RB. Vasoconstrictor assay - specific applications. In: Maibach HI, Surber C, eds. Topical Corticosteroids. Basel, Switzerland: Karger; 1992:42-53.
10. Ostrenga J, Steinmetz C, Poulsen B. Significance of vehicle composition 1: Relationship between topical vehicle composition, skin penetrability, and clinical efficacy. J Pharm Sci. 1971;60:1175-1179.
11. Bluefarb SM, Howard FM, Liebsohn E, Schlagel CA, Wexler L. Diflorasone diacetate: vasoconstrictor activity and clinical efficacy of a new topical corticosteroid, J Int Med Res. 1976;4:454-457.
12. Augustine MA. Relation of vehicle to corticosteroid potency. In: Frost P, Gomez EG, Zaias N, eds. Recent Advances in Dermatopharmacology. New York, NY: Spectrum Publications; 1978:113-120.
13. Franz TJ, Parsell DA, Halualani RM, et al. Betamethasone valerate foam 0.12%: a novel vehicle with enhanced delivery and efficacy. Int J Dermatol. 1999;38:628-632.
14. Shaw JE, Chandrasekaran SK, Michaels AS, Taskovich L. Controlled transdermal delivery, in vitro and in vivo. In: Maibach HI, ed. Animal Models in Dermatology. New York, NY: Churchill Livingstone; 1975:138-146.
15. Venkateshwaran S. In vitro-in vivo correlation for transdermal delivery. Paper presented at: IBC International Conference on Transdemal Drug Delivery; 15-16 December 1997; Coronado, CA:.
16. FDA, CDER. Summary Basis of Approval: NDA 21-145 Eflornithine Hydrochloride. Pharmacologist' Review. Rockville, MD: FDA; 1995.
17. Van Buskirk GA, Shah VP, Adair D, et al. Workshop III report: scale-up of liquid and semisolid disperse systems. Pharm Res. 1994;11:1216-1220.
18. Organisation for Economic Cooperation and Development. Guideline for Testing of Chemicals No. 428: Skin Absorption: In vitro methods. Paris, France: OECD; 2004:1-8.
19. AAPS/FDA. Workshop on Principles and Practices of In Vitro Percutaneous Penetration Studies as Related to Bioavailability and Bioequivalence; 31 October-1 November 1986; Washington, DC.
20. AAPS/FDA. Workshop on Assessment of Value and Applications of In Vitro Testing of Topical Dermatological Drug Products; 8-10 September 1997; Arlington, VA.
21. FDA, CDER. Guidance: topical dermatological drug product NDAs and ANDAs - in vivo bioavailability, bioequivalence, in vitro release, and associated studies. draft guidance. (1998). Available at: http://www.fda.gov/ohrms/dockets/ac/00/backgrd/3661blc.pdf. (Accessed 18 March 2008).
22. Lehman PA, Agrawal N, Spear KL, Franz TJ. Generic tretinoin gels: demonstration of bioequivalence by pharmacodynamic and pharmacokinetic assay. J Invest Dermatol. 1999;112:65.
23. Papa CM. The cutaneous safety of topical tretinoin. Acta Derm Vernereol (Stockh). 1985;74(suppl 55):128-132.
24. Leyden JJ. Topical treatment of acne vulgaris: retinoids and cutaneous irritation. J Am Acad Dermatol. 1998;38:S1-S4.