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首页> 外文期刊>The Journal of dermatology >Application of the Food and Drug Administration (FDA) bioequivalent guidance of topical dermatological corticosteroid in yellow-skinned Japanese population: validation study using a chromameter.
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Application of the Food and Drug Administration (FDA) bioequivalent guidance of topical dermatological corticosteroid in yellow-skinned Japanese population: validation study using a chromameter.

机译：食品和药物管理局（FDA）在黄色皮肤的日本人群中局部皮肤科用糖皮质激素的生物等效指导的应用：使用色谱仪的验证研究。

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The American Food and Drug Administration (FDA) bioequivalent guidance of topical dermatological corticosteroids in 1995 (the Guidance) requires measurement of the skin blanching response with a chromameter for evaluation of cutaneously applied corticosteroid formulations. The Japanese government decided to apply the same guidelines in 2003, despite there having been no reported trial for the yellow-skinned races. The purpose of this study was to obtain basic data of corticosteroid-induced skin blanching response measured with a chromameter on yellow-skinned races. Four studies were performed according to the Japanese version of the Guidance for Industry using a chromameter on the forearms of healthy Japanese volunteers. This involved: (i) a validation study of proper duration of treatment exposure (dose duration); (ii) a comparison study of two dermatological corticosteroid products that represented different potency classes; (iii) inspection of reproducibility using right and left forearms; and (iv) study of seasonal difference. We showed that: (i) the same medication can give different values of ED(50) (the dose duration required to achieve 50% of the fitted areas under the effect curves [AUEC](max) value) under different dose durations; (ii) ED(50) do not always represent the potency of the corticosteroid; (iii) the results of AUEC at maximum duration were similar, but AUEC at an approximate ED(50) duration time varied widely; and (iv) the results of AUEC were different according to season. In conclusion the dose duration relationships, determination of the AUEC(max), and the ED(50) could be obtained on yellow-skinned races using the FDA method. However, negligible differences were found in our study regarding dose duration, reproducibility and seasonal change.
机译：1995年，美国食品药品监督管理局（FDA）的局部皮肤用皮质类固醇生物等效指南（该指南）要求使用色度计测量皮肤的变白反应，以评估皮肤应用的皮质类固醇制剂。尽管没有关于黄皮肤种族的审判的报道，日本政府还是在2003年决定采用相同的指导方针。这项研究的目的是获得用色度计在黄皮人种上测量的皮质类固醇诱导的皮肤变白反应的基本数据。根据日语版的《工业指南》，使用色谱仪对健康的日本志愿者的前臂进行了四项研究。这涉及：（i）适当治疗暴露持续时间（剂量持续时间）的验证研究; （ii）两种代表不同功效类别的皮肤科皮质类固醇激素产品的比较研究; （iii）使用右前臂和左前臂检查可重复性; （iv）研究季节差异。我们发现：（i）同一药物在不同剂量下可以提供不同的ED（50）值（在效果曲线[AUEC]（max）值下达到50％的拟合区域所需的剂量时长）; （ii）ED（50）并不总是代表皮质类固醇的效力; （iii）在最大持续时间下的AUEC结果相似，但是在大约ED（50）持续时间下的AUEC差异很大; （iv）AUEC的结果因季节而异。总之，剂量持续时间关系，AUEC（max）和ED（50）的确定可以使用FDA方法在黄皮肤的种族上获得。但是，在我们的研究中发现剂量持续时间，可重复性和季节变化方面的差异可忽略不计。

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