| Literature DB >> 12145427 |
E W Smith1, J M Haigh, C Surber.
Abstract
Topical corticosteroid formulations have been evaluated by visual grading protocols for many years. Toward a more objective methodology, several instrumental methods have been evaluated for applicability in quantifying the vasoconstriction side-effect that follows corticosteroid application to the skin. Although the chromameter has been adopted by regulatory bodies throughout the world as the current standard for topical bioequivalence determinations, there is considerable criticism of this instrument from several quarters. A preliminary comparison reported here indicates that digital image analysis provides statistically significant results that are similar to those obtained by visual assessment techniques, and shows considerably greater precision than that obtained by the chromameter. Continued evaluation of objective assessment techniques, such as digital imaging, and continued modernisation of regulatory bioequivalence requirements will assist in protecting patients and optimising clinical results. Copyright 2002 S. Karger AG, BaselEntities:
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Year: 2002 PMID: 12145427 DOI: 10.1159/000063144
Source DB: PubMed Journal: Dermatology ISSN: 1018-8665 Impact factor: 5.366