The human skin-blanching assay for in vitro topical corticosteroid assessment. I. Reproducibility of the assay

Haigh, J.M. and Meyer, E. and Smith, E.W. and Kanfer, I. (1997) The human skin-blanching assay for in vitro topical corticosteroid assessment. I. Reproducibility of the assay. International Journal of Pharmaceutics, 152 (2). pp. 179-183. ISSN 0378-5173

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Official URL: http://dx.doi.org/10.1016/S0378-5173(97)00078-1

Abstract

The human skin blanching (vasoconstriction) assay for the assessment of topical corticosteroids has been in use for over 30 years, the intensity of the drug-induced blanching being assessed subjectively by eye. Both arms of several male and female volunteers are used for product application and more than one observer is used to estimate the degree of induced blanching. There are, therefore, numerous variables which are inherent in the assay procedure. This investigation consisted of three identical trials performed at 8-week intervals, utilising the same 18 volunteers and the same three observers in an attempt to address the question of reproducibility of the assay. From the results obtained it is clear that the assay methodology is capable of consistently distinguishing, on a rank order basis, between preparations which show similar blanching (chemically-equivalent formulations). The similarity of the results for the three individual trials gives considerable confidence to results produced using this methodology. An experiment designed to test the reproducibility of the blanching scores showed that the observers are capable of producing identical results even though visual observation is highly subjective.

Item Type:Article
Uncontrolled Keywords:Topical corticosteroids; Human skin blanching assay; Reproducibility
Subjects:Y Unknown > Subjects to be assigned
Divisions:Faculty > Faculty of Pharmacy
ID Code:631
Deposited By: Prof John Haigh
Deposited On:31 May 2007
Last Modified:06 Jan 2012 16:18
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