Are generic formulations equivalent to trade name topical glucocorticoids?

Stoughton, Richard B.

doi:10.1001/archderm.123.10.1312

Cited by 16 publications

(4 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%

Quantification of Corticosteroid-Induced Skin Vasoconstriction: Visual Ranking, Chromameter Measurement or Digital Imaging Analysis

Smith

Haigh²,

Surber³

2002

Dermatology

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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.

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Section: Visual Assessmentmentioning

confidence: 99%

Quantification of Corticosteroid-Induced Skin Vasoconstriction: Visual Ranking, Chromameter Measurement or Digital Imaging Analysis

Smith

Haigh²,

Surber³

2002

Dermatology

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“…This was further confirmed in a study documented by Poulsen & Rorsman (1980)where corticosteroid in an ointment formulation were found to be of a higher potency classification, as determined by the skin blanching assay, than the equivalent cream formulation. Stoughton (1987), later used the skin blanching assay to determine the bioequivalence of generic and trade TCSs, finding certain TCS formulations to produce inequivalent vasoconstrictive effects despite containing equal concentrations of the active drug. The , 2018).…”

Section: Disease Management and Therapeutic Approachesmentioning

confidence: 99%

Topically Applied therapies for the treatment of skin disease : Past Present and Future

Brown,

Williams,

Chilcott

et al. 2024

Pharmacol Rev

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“…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%

Generic drugs - safe, effective, and affordable

Peters

Hixon

Conner

et al. 2009

Dermatologic Therapy

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This article discusses the history and evolution of the process for generic drug evaluation and approval in the United States, with emphasis on locally acting dermatologic products. The requirements for in vivo bioequivalence (BE) testing and the statistical criteria for BE are discussed, and an example of a topical antifungal dermatologic product is used to demonstrate the BE determination for locally acting drugs. Other factors in the dispensing of prescription medications that are not within the Food and Drug Administration regulatory authority are also mentioned.

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Are generic formulations equivalent to trade name topical glucocorticoids?

Cited by 16 publications

References 0 publications

Quantification of Corticosteroid-Induced Skin Vasoconstriction: Visual Ranking, Chromameter Measurement or Digital Imaging Analysis

Quantification of Corticosteroid-Induced Skin Vasoconstriction: Visual Ranking, Chromameter Measurement or Digital Imaging Analysis

Topically Applied therapies for the treatment of skin disease : Past Present and Future

Generic drugs - safe, effective, and affordable

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