-
1
-
-
18244412104
-
Bioequivalence of topical dermatological dosage forms - methods of evaluation of bioequivalence
-
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. Shrivastava, J. Wilkin, and R. L. Williams. Bioequivalence of topical dermatological dosage forms - methods of evaluation of bioequivalence. Pharm. Res., 15:167-171, 1998.
-
(1998)
Pharm. Res.
, vol.15
, pp. 167-171
-
-
Shah, V.P.1
Flynn, G.L.2
Yacobi, A.3
Maibach, H.I.4
Bon, C.5
Fleischer, N.M.6
Franz, T.J.7
Kaplan, S.A.8
Kawamoto, J.9
Lesko, L.J.10
Marty, J.-P.11
Pershing, L.K.12
Schaefer, H.13
Sequeira, J.A.14
Shrivastava, S.P.15
Wilkin, J.16
Williams, R.L.17
-
2
-
-
78650369451
-
Guidance for industry: Topical dermatological corticosteroids: In vivo bioequivalence
-
FDA., Food and Drug Administration, MD, USA
-
FDA. Guidance for industry: topical dermatological corticosteroids: in vivo bioequivalence. Center for Drug Evaluation, Food and Drug Administration, MD, USA 1995.
-
(1995)
Center For Drug Evaluation
-
-
-
6
-
-
78650401055
-
-
MCC, Medicines Control Council, South Africa
-
MCC. Biostudies Guideline. Medicines Control Council, South Africa 2007.
-
(2007)
Biostudies Guideline
-
-
-
7
-
-
84941818257
-
Method for comparing percutaneous absorption of steroids
-
A. W. McKenzie and R. B. Stoughton. Method for comparing percutaneous absorption of steroids. Arch. Dermatol., 86:608-610, 1962.
-
(1962)
Arch. Dermatol.
, vol.86
, pp. 608-610
-
-
McKenzie, A.W.1
Stoughton, R.B.2
-
8
-
-
0022478691
-
The measurement of the stratum corneum reservoir: A simple method to predict the influence of vehicles on in vivo percutaneous absorption
-
D. Dupuis, A. Rougier, R. Roguet, and C. Lotte. The measurement of the stratum corneum reservoir: a simple method to predict the influence of vehicles on in vivo percutaneous absorption. Brit. J. Dermatol., 115:233-238, 1986.
-
(1986)
Brit. J. Dermatol.
, vol.115
, pp. 233-238
-
-
Dupuis, D.1
Rougier, A.2
Roguet, R.3
Lotte, C.4
-
9
-
-
42749086446
-
Lipid nanoparticles for prolonged topical delivery: An in vitro and in vivo investigation
-
C. Puglia, P. Blasi, L. Rizza, A. Schoubben, F. Bonina, C. Rossi, and M. Ricci. Lipid nanoparticles for prolonged topical delivery: An in vitro and in vivo investigation. Int. J. Pharm., 357:295-304, 2008.
-
(2008)
Int. J. Pharm.
, vol.357
, pp. 295-304
-
-
Puglia, C.1
Blasi, P.2
Rizza, L.3
Schoubben, A.4
Bonina, F.5
Rossi, C.6
Ricci, M.7
-
10
-
-
0032828440
-
Distribution of salicylic acid in human stratum corneum following topical application in vivo: A comparison of six different formulations
-
J. C. Tsai, S. A. Chuang, M. Y. Hsu, and H. M. Sheu. Distribution of salicylic acid in human stratum corneum following topical application in vivo: a comparison of six different formulations. Int. J. Pharm., 188:145-153, 1999.
-
(1999)
Int. J. Pharm.
, vol.188
, pp. 145-153
-
-
Tsai, J.C.1
Chuang, S.A.2
Hsu, M.Y.3
Sheu, H.M.4
-
11
-
-
0026560393
-
Lamellar body secretory response to barrier disruption
-
G. K. Menon, K. R. Feingold, and P. M. Elias. Lamellar body secretory response to barrier disruption. J. Invest. Dermatol., 98:279-289, 1992.
-
(1992)
J. Invest. Dermatol.
, vol.98
, pp. 279-289
-
-
Menon, G.K.1
Feingold, K.R.2
Elias, P.M.3
-
12
-
-
38049129770
-
In vivo methods for the assessment of topical drug bioavailability
-
C. Herkenne, I. Alberti, A. Naik, Y. N. Kalia, F.-X. Mathy, V. Préat, and R. H. Guy. In vivo methods for the assessment of topical drug bioavailability. Pharm. Res., 25:87-103, 2008.
-
(2008)
Pharm. Res.
, vol.25
, pp. 87-103
-
-
Herkenne, C.1
Alberti, I.2
Naik, A.3
Kalia, Y.N.4
Mathy, F.-X.5
Préat, V.6
Guy, R.H.7
-
13
-
-
33845761775
-
Bioequivalence of topical formulations in humans: Evaluation by dermal microdialysis sampling and the dermatopharmacokinetic method
-
E. Benfeldt, S. H. Hansen, A. Vølund, T. Menné, and V. P. Shah. Bioequivalence of topical formulations in humans: evaluation by dermal microdialysis sampling and the dermatopharmacokinetic method. J. Invest. Dermatol., 127:170-178, 2007.
-
(2007)
J. Invest. Dermatol.
, vol.127
, pp. 170-178
-
-
Benfeldt, E.1
Hansen, S.H.2
Vølund, A.3
Menné, T.4
Shah, V.P.5
-
14
-
-
44749086444
-
Optimizing metrics for the assessment of bioequivalence between topical drug products
-
B. N'Dri-Stempfer, W. C. Navidi, R. H. Guy, and A. L. Bunge. Optimizing metrics for the assessment of bioequivalence between topical drug products. Pharm. Res., 25:1621-1630, 2008.
-
(2008)
Pharm. Res.
, vol.25
, pp. 1621-1630
-
-
N'dri-Stempfer, B.1
Navidi, W.C.2
Guy, R.H.3
Bunge, A.L.4
-
15
-
-
0038623641
-
Assessment of dermatopharmacokinetic approach in the bioequivalence determination of topical tretinoin gel products
-
L. K. Pershing, J. L. Nelson, J. L. Corlett, S. P. Shrivastava, 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.
-
(2003)
J. Am. Acad. Dermatol.
, vol.48
, pp. 740-751
-
-
Pershing, L.K.1
Nelson, J.L.2
Corlett, J.L.3
Shrivastava, S.P.4
Hare, D.B.5
Shah, V.P.6
-
16
-
-
0345863514
-
Evaluation of in vivo bioequivalence methodology for topical clobetasol 17-propionate based on pharmacodynamic modeling using chinese skin
-
J. C. Tsai, C. L. Cheng, Y. F. Tsai, H. M. Sheu, and C. H. Chou. Evaluation of in vivo bioequivalence methodology for topical clobetasol 17-propionate based on pharmacodynamic modeling using chinese skin. J. Pharm. Sci., 93:207-217, 2004.
-
(2004)
J. Pharm. Sci.
, vol.93
, pp. 207-217
-
-
Tsai, J.C.1
Cheng, C.L.2
Tsai, Y.F.3
Sheu, H.M.4
Chou, C.H.5
-
17
-
-
0026464035
-
Variability and correlation of chromameter and tape-stripping methods with the visual skin blanching assay in quantitative assessment of topical 0.05% betamethasone dipropionate bioavailability in humans
-
L. K. Pershing, L. D. Lambert, V. P. Shah, and S. Y. Lam. Variability and correlation of chromameter and tape-stripping methods with the visual skin blanching assay in quantitative assessment of topical 0.05% betamethasone dipropionate bioavailability in humans. Int. J. Pharm., 86:201-210, 1992.
-
(1992)
Int. J. Pharm.
, vol.86
, pp. 201-210
-
-
Pershing, L.K.1
Lambert, L.D.2
Shah, V.P.3
Lam, S.Y.4
-
18
-
-
0026570431
-
Feasibility of measuring the bioavailability of topical betamethasone dipropionate in commercial formulations using drug content in skin and a skin blanching bioassay
-
L. K. Pershing, B. S. Silver, G. G. Krueger, V. P. Shah, and P. Skelley. Feasibility of measuring the bioavailability of topical betamethasone dipropionate in commercial formulations using drug content in skin and a skin blanching bioassay. Pharm. Res., 9:45-51, 1992.
-
(1992)
Pharm. Res.
, vol.9
, pp. 45-51
-
-
Pershing, L.K.1
Silver, B.S.2
Krueger, G.G.3
Shah, V.P.4
Skelley, P.5
-
19
-
-
0033761878
-
Normalization of stratum corneum barrier function and transepidermal water loss in vivo
-
Y. N. Kalia, I. Alberti, N. Sekkat, C. Curdy, A. Naik, and R. H. Guy. Normalization of stratum corneum barrier function and transepidermal water loss in vivo. Pharm. Res., 17:1148-1150, 2000.
-
(2000)
Pharm. Res.
, vol.17
, pp. 1148-1150
-
-
Kalia, Y.N.1
Alberti, I.2
Sekkat, N.3
Curdy, C.4
Naik, A.5
Guy, R.H.6
-
21
-
-
53549115634
-
Bioequivalence assessment of topical clobetasol propionate products using visual and chromametric assessment of skin blanching
-
W. L. Au, M. Skinner, and I. Kanfer, Bioequivalence assessment of topical clobetasol propionate products using visual and chromametric assessment of skin blanching. J. Pharm. Pharmaceut. Sci, 11:147-153, 2008.
-
(2008)
J. Pharm. Pharmaceut. Sci.
, vol.11
, pp. 147-153
-
-
Au, W.L.1
Skinner, M.2
Kanfer, I.3
-
22
-
-
0019785890
-
Understanding the dose-effect relationship: Clinical application of pharmacokinetic-pharmacodynamic models
-
N. H. G. Holford and L. B. Sheiner. Understanding the dose-effect relationship: clinical application of pharmacokinetic-pharmacodynamic models. Clin. Pharmacokinet., 6:429-453, 1981.
-
(1981)
Clin. Pharmacokinet.
, vol.6
, pp. 429-453
-
-
Holford, N.H.G.1
Sheiner, L.B.2
-
23
-
-
0026644451
-
Sensitivity of different areas of the flexor aspect of the human forearm to corticosteroid-induced skin blanching
-
E. Meyer, E. W. Smith, and J. M. Haigh. Sensitivity of different areas of the flexor aspect of the human forearm to corticosteroid-induced skin blanching. Brit. J. Dermatol., 127:379-381, 1992.
-
(1992)
Brit. J. Dermatol.
, vol.127
, pp. 379-381
-
-
Meyer, E.1
Smith, E.W.2
Haigh, J.M.3
-
24
-
-
0033061547
-
Bioavailability of clobetasol propionate - quantification of drug concentrations in the stratum corneum by dermatopharmacokinetics using tape stripping. Skin Pharmacol
-
H. J. Weigmann, J. Lademann, R. von Pelchrzim, W. Sterry, T. Hagemeister, R. Molzahn, M. Schaefer, M. Lindscheid, H. Schaefer, and V. P. Shah. Bioavailability of clobetasol propionate - quantification of drug concentrations in the stratum corneum by dermatopharmacokinetics using tape stripping. Skin Pharmacol. Appl. Skin Physiol., 12:46-53, 1999.
-
(1999)
Appl. Skin Physiol.
, vol.12
, pp. 46-53
-
-
Weigmann, H.J.1
Lademann, J.2
von Pelchrzim, R.3
Sterry, W.4
Hagemeister, T.5
Molzahn, R.6
Schaefer, M.7
Lindscheid, M.8
Schaefer, H.9
Shah, V.P.10
-
25
-
-
0003484310
-
-
FDA. Center for Drug Evaluation and Research, Food and Drug Administration, MD, USA
-
FDA. Guidance for industry: bioanalytical method validation. Center for Drug Evaluation and Research, Food and Drug Administration, MD, USA, 2001.
-
(2001)
Guidance For Industry: Bioanalytical Method Validation
-
-
-
26
-
-
58149147317
-
Application of dermal microdialysis for the evaluation of bioequivalence of a ketoprofen topical gel
-
R. N. O. Tettey-Amlalo, I. Kanfer, M. F. Skinner, E. Benfeldt, and R. K. Verbeeck. Application of dermal microdialysis for the evaluation of bioequivalence of a ketoprofen topical gel. Eur. J. Pharm. Sci., 36:219-225, 2009.
-
(2009)
Eur. J. Pharm. Sci.
, vol.36
, pp. 219-225
-
-
Tettey-Amlalo, R.N.O.1
Kanfer, I.2
Skinner, M.F.3
Benfeldt, E.4
Verbeeck, R.K.5
-
27
-
-
0025958371
-
Sample size determination for bioequivalence assessment by means of confidence intervals
-
E. Diletti, D. Hauschke, and V. W. Steinijans. Sample size determination for bioequivalence assessment by means of confidence intervals. Int. J. Clin. Pharmacol. Ther. Toxic., 29:1-8, 1991.
-
(1991)
Int. J. Clin. Pharmacol. Ther. Toxic.
, vol.29
, pp. 1-8
-
-
Diletti, E.1
Hauschke, D.2
Steinijans, V.W.3
-
28
-
-
0023615056
-
A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability
-
D. J. Schuirmann. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J. Pharmacokin. Biopharm., 15:657-680, 1987.
-
(1987)
J. Pharmacokin. Biopharm.
, vol.15
, pp. 657-680
-
-
Schuirmann, D.J.1
-
29
-
-
0021702968
-
An exact confidence interval for unstransformed data for the ratio of two formulation means
-
C. S. Locke. An exact confidence interval for unstransformed data for the ratio of two formulation means. J. Pharmacokin. Biopharm., 12:649-655, 1984.
-
(1984)
J. Pharmacokin. Biopharm.
, vol.12
, pp. 649-655
-
-
Locke, C.S.1
|