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July 1991

Topical Corticosteroid-Induced Skin Blanching Measurement: Eye or Instrument?-Reply

Author Affiliations

Center for Drug Evaluation and Research Food and Drug Administration Rockville, MD 20857

Arch Dermatol. 1991;127(7):1065. doi:10.1001/archderm.1991.01680060141026

In Reply.—  The authors focused on the assets and limitations of current procedures for bioequivalence testing of topically applied corticosteroids, subsequent to Stoughton's lentication,1 which indicated that there were bioinequivalent approved topical generic glucocorticoid products in the American marketplace. At that time, the highly subjective skin blanching assay using only one time point measurement had been the basis of establishing generic product equivalence.The thrust of our article2 was twofold: (1) there was a need for an objective measurement using a standardized validated procedure for regulatory scientific evaluation; and (2) we indicated that "The value of multipoint determinations should be investigated," because we thought that such a profile would be amenable to area under the curve (AUC) analysis.While we certainly encourage the utilization of objective measurements (especially for regulatory submissions), a conclusion that we are dissuading potential researchers from using this valuable (albeit highly subjective) assay would

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