1987
DOI: 10.1001/archderm.123.10.1312
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Are generic formulations equivalent to trade name topical glucocorticoids?

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Cited by 15 publications
(3 citation statements)
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“…The methodology of the visual assessment assay, its sensitivity and reproducibility, have previously been documented at length [8, 10, 11, 16]. The visual methodology is routinely conducted for comparing two formulations containing the same corticosteroid in the same concentration [19], or for comparing different corticosteroids for clinical potency ranking [17]. This grading system has substantial theoretical merit: the human eye is an excellent discriminator of differences between very similar colours.…”
Section: Visual Assessmentmentioning
confidence: 99%
“…The methodology of the visual assessment assay, its sensitivity and reproducibility, have previously been documented at length [8, 10, 11, 16]. The visual methodology is routinely conducted for comparing two formulations containing the same corticosteroid in the same concentration [19], or for comparing different corticosteroids for clinical potency ranking [17]. This grading system has substantial theoretical merit: the human eye is an excellent discriminator of differences between very similar colours.…”
Section: Visual Assessmentmentioning
confidence: 99%
“…Richard Stoughton and others developed and tested a vasoconstrictor assay that proved to be an excellent system for predicting clinical activity of a topical steroid formulation. Stoughton used this assay to compare a number of topical glucocorticoid preparations to their generic equivalents and demonstrated some striking differences in activity between formulations that had been considered bioequivalent (8). As noted later by Smith et al (9), "It has become evident that incorporating identical concentrations of the same drug into two different topical vehicles (chemical equivalency) does not necessarily produce dosage forms that will deliver the active drug to the biosystem at the same rate or to the same extent.…”
Section: Overview Of Generic Drugsmentioning
confidence: 99%
“…18,19 This assay, which measures the vasoconstrictor effect to measure the corticoid activity, is recognized by the Food and Drug Administration (FDA) as a bioequivalent method. 20,21 Nevertheless, the FDA identifies in vitro studies as interesting surrogates with regard to topical bioequivalence. 22 Franz et al 23 reported the use of excised skin to specifically demonstrate the bioequivalence of topical products using the finite dose method.…”
mentioning
confidence: 99%