메뉴 건너뛰기




Volumn , Issue , 2007, Pages 549-562

An industry perspective of topical dermal bioequivalence

Author keywords

[No Author keywords available]

Indexed keywords


EID: 78650370641     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter
Times cited : (1)

References (30)
  • 2
    • 0035659563 scopus 로고    scopus 로고
    • Bioavailability and bioequivalence: An FDA regulatory overview
    • Chen M, Shah V, Patnaik R, et al. Bioavailability and bioequivalence: an FDA regulatory overview. Pharm Res 2001; 18:1645-50.
    • (2001) Pharm Res , vol.18 , pp. 1645-1650
    • Chen, M.1    Shah, V.2    Patnaik, R.3
  • 3
    • 85056947590 scopus 로고    scopus 로고
    • Title 21 Code of Federal Regulations (CFR) Part 320.21, April
    • FDA, Title 21 Code of Federal Regulations (CFR) Part 320.21, April 2005.
    • (2005)
  • 4
    • 85056954710 scopus 로고    scopus 로고
    • FDA Guidance for Industry. Nonsterile Semisolid Dosage Forms
    • Vitro Release Testing and In Vivo Bioequivalence Documentation, May
    • FDA Guidance for Industry. Nonsterile Semisolid Dosage Forms, Scale-Up and Postapproval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation, May 1997.
    • (1997) Scale-Up and Postapproval Changes: Chemistry, Manufacturing and Controls
  • 7
    • 18244412104 scopus 로고    scopus 로고
    • Bioequivalence of topical dermatological dosage forms-methods of evaluation of bioequivalence
    • Shah V, Flynn G, Yacobi A, et al. Bioequivalence of topical dermatological dosage forms-methods of evaluation of bioequivalence. Pharm Res 1998; 15:167-71.
    • (1998) Pharm Res , vol.15 , pp. 167-171
    • Shah, V.1    Flynn, G.2    Yacobi, A.3
  • 8
    • 0013974050 scopus 로고
    • The concentrations of free amino acids and other electrolytes in cerebrospinal fluid, in vivo dialysate of brain and blood plasma of the dog
    • Bito L, Davson H, Levin E, et al. The concentrations of free amino acids and other electrolytes in cerebrospinal fluid, in vivo dialysate of brain and blood plasma of the dog. J Neurochem 1966; 13:1057-67.
    • (1966) J Neurochem , vol.13 , pp. 1057-1067
    • Bito, L.1    Davson, H.2    Levin, E.3
  • 10
    • 0025044931 scopus 로고
    • Microdialysis-theory and application
    • Benveniste H, Hüttemeier P. Microdialysis-theory and application. Prog Neurobiol 1990; 3:195-215.
    • (1990) Prog Neurobiol , vol.3 , pp. 195-215
    • Benveniste, H.1    Hüttemeier, P.2
  • 11
    • 0030942858 scopus 로고    scopus 로고
    • Application of microdialysis in pharmacokinetic studies
    • Elmquist W, Sawchuk R. Application of microdialysis in pharmacokinetic studies. Pharm Res 1997; 14:267-88.
    • (1997) Pharm Res , vol.14 , pp. 267-288
    • Elmquist, W.1    Sawchuk, R.2
  • 12
    • 0031617364 scopus 로고    scopus 로고
    • Cutaneous microdialysis-a new technique for the assessment of skin penetration
    • Groth L. Cutaneous microdialysis-a new technique for the assessment of skin penetration. Curr Probl Dermatol 1998; 26:90-8.
    • (1998) Curr Probl Dermatol , vol.26 , pp. 90-98
    • Groth, L.1
  • 13
    • 0006938780 scopus 로고    scopus 로고
    • Cutaneous microdialysis of human in vivo dermal absorption studies
    • Robert MS, Walters KA, eds, 1st ed. New York: Marcel Dekker Inc
    • Anderson C, Anderson T, Boman A. Cutaneous microdialysis of human in vivo dermal absorption studies. In:Robert MS, Walters KA, eds. Dermal Absorption and Toxicity Assessment. 1st ed. New York: Marcel Dekker Inc., 1998;231-44.
    • (1998) Dermal Absorption and Toxicity Assessment , pp. 231-244
    • Anderson, C.1    Anderson, T.2    Boman, A.3
  • 14
    • 0034672531 scopus 로고    scopus 로고
    • Microdialysis in clinical drug delivery studies
    • Müller M. Microdialysis in clinical drug delivery studies. Adv Drug Deliv Rev 2000; 45:255-69.
    • (2000) Adv Drug Deliv Rev , vol.45 , pp. 255-269
    • Müller, M.1
  • 16
    • 0036072857 scopus 로고    scopus 로고
    • Comparison of skin stripping, in vitro release and skin blanching response methods to measure dose response and similarity of triamcinolone acetonide cream strengths from two manufactured sources
    • Pershing L, Bakhtian S, Poncelet C, et al. Comparison of skin stripping, in vitro release and skin blanching response methods to measure dose response and similarity of triamcinolone acetonide cream strengths from two manufactured sources. J Pharm Sci 2002; 91:1312-23.
    • (2002) J Pharm Sci , vol.91 , pp. 1312-1323
    • Pershing, L.1    Bakhtian, S.2    Poncelet, C.3
  • 17
    • 0035734003 scopus 로고    scopus 로고
    • Correlation of the local distribution of topically applied substances inside the stratum corneum determined by tape-stripping to differences in bioavailability
    • Weigmann H, Lademann J, Schanzer S, et al. Correlation of the local distribution of topically applied substances inside the stratum corneum determined by tape-stripping to differences in bioavailability. Skin Pharmacol Appl Skin Physiol 2001; 14(Suppl. 1):98-102.
    • (2001) Skin Pharmacol Appl Skin Physiol , vol.14 , pp. 98-102
    • Weigmann, H.1    Lademann, J.2    Schanzer, S.3
  • 18
    • 0006120819 scopus 로고    scopus 로고
    • Microdialysis vs. suction blister technique for in vivo sampling of pharmacokinetics in the human dermis
    • Benfeldt E, Serup J, Menné T. Microdialysis vs. suction blister technique for in vivo sampling of pharmacokinetics in the human dermis. Acta Derm Venereol 1999; 79:338-42.
    • (1999) Acta Derm Venereol , vol.79 , pp. 338-342
    • Benfeldt, E.1    Serup, J.2    Menné, T.3
  • 20
    • 0028917147 scopus 로고
    • Application of microdialysis to clinical pharmacokinetics in humans
    • Müller M, Schmid R, Georgopoulos A, et al. Application of microdialysis to clinical pharmacokinetics in humans. Clin Pharmacol Ther 1995; 57:371-80.
    • (1995) Clin Pharmacol Ther , vol.57 , pp. 371-380
    • Müller, M.1    Schmid, R.2    Georgopoulos, A.3
  • 21
    • 0036851560 scopus 로고    scopus 로고
    • Assessment of cutaneous drug delivery using microdialysis
    • Kreilgaard K. Assessment of cutaneous drug delivery using microdialysis. Adv Drug Deliv Rev 2002; 54:S99-121.
    • (2002) Adv Drug Deliv Rev , vol.54 , pp. S99-S121
    • Kreilgaard, K.1
  • 23
    • 0034954840 scopus 로고    scopus 로고
    • Influence of a microemulsion vehicle on cutaneous bioequivalence of a lipophilic model drug assessed by microdialysis and pharmacodynamics
    • Kreilgaard M, Kemme M, Burggraaf J, et al. Influence of a microemulsion vehicle on cutaneous bioequivalence of a lipophilic model drug assessed by microdialysis and pharmacodynamics. Pharm Res 2001; 18:593-9.
    • (2001) Pharm Res , vol.18 , pp. 593-599
    • Kreilgaard, M.1    Kemme, M.2    Burggraaf, J.3
  • 24
    • 0030782930 scopus 로고    scopus 로고
    • Diclofenac concentrations in defined tissue layers after topical administration
    • Müller M, Mascher H, Kikuta C, et al. Diclofenac concentrations in defined tissue layers after topical administration. Clin Pharmacol Ther 1997; 62:293-9.
    • (1997) Clin Pharmacol Ther , vol.62 , pp. 293-299
    • Müller, M.1    Mascher, H.2    Kikuta, C.3
  • 25
    • 0032956970 scopus 로고    scopus 로고
    • Effect of barrier perturbation on cutaneous salicylic acid penetration in human skin: In vivo pharmacokinetics using microdialysis and noninvasive quantification of barrier function
    • Benfeldt E, Serup J, Menné T. Effect of barrier perturbation on cutaneous salicylic acid penetration in human skin: in vivo pharmacokinetics using microdialysis and noninvasive quantification of barrier function. Br J Dermatol 1999; 140:739-48.
    • (1999) Br J Dermatol , vol.140 , pp. 739-748
    • Benfeldt, E.1    Serup, J.2    Menné, T.3
  • 26
    • 0033047277 scopus 로고    scopus 로고
    • Application of microdialysis for the determination of muscle and subcutaneous tissue concentrations after oral and topical ibuprofen administration
    • Tegeder I, Muth-Selbach U, Lötsch J, et al. Application of microdialysis for the determination of muscle and subcutaneous tissue concentrations after oral and topical ibuprofen administration. Clin Pharmacol Ther 1999; 65:357-68.
    • (1999) Clin Pharmacol Ther , vol.65 , pp. 357-368
    • Tegeder, I.1    Muth-Selbach, U.2    Lötsch, J.3
  • 27
    • 0029074055 scopus 로고
    • Microdialysis in cutaneous pharmacology: Kinetic analysis of transdermally delivered nicotine
    • Hegemann L, Forstinger C, Partsch B, et al. Microdialysis in cutaneous pharmacology:kinetic analysis of transdermally delivered nicotine. J Invest Dermatol 1995; 104:839-43.
    • (1995) J Invest Dermatol , vol.104 , pp. 839-843
    • Hegemann, L.1    Forstinger, C.2    Partsch, B.3
  • 28
    • 0031786554 scopus 로고    scopus 로고
    • Transdermal penetration of diclofenac after multiple epicutaneous administration
    • Müller M, Rastelli C, Ferri P, et al. Transdermal penetration of diclofenac after multiple epicutaneous administration. J Rheumatol 1998; 25:1833-6.
    • (1998) J Rheumatol , vol.25 , pp. 1833-1836
    • Müller, M.1    Rastelli, C.2    Ferri, P.3
  • 29
    • 0031859098 scopus 로고    scopus 로고
    • Topical penetration of commercial salicylate esters and salts using human isolated skin and clinical microdialysis studies
    • Cross S, Anderson C, Roberts M. Topical penetration of commercial salicylate esters and salts using human isolated skin and clinical microdialysis studies. Br J Clin Pharmacol 1998; 46:29-35.
    • (1998) Br J Clin Pharmacol , vol.46 , pp. 29-35
    • Cross, S.1    Anderson, C.2    Roberts, M.3
  • 30
    • 0032929613 scopus 로고    scopus 로고
    • Self promotion of deep tissue penetration and distribution of methylsalicylate after topical application
    • Cross S, Megwa S, Benson H, et al. Self promotion of deep tissue penetration and distribution of methylsalicylate after topical application. Pharm Res 1999; 16:427-33.
    • (1999) Pharm Res , vol.16 , pp. 427-433
    • Cross, S.1    Megwa, S.2    Benson, H.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.