Olsen E A
Duke University Medical Center, Durham, North Carolina 27710.
Int J Dermatol. 1992 Oct;31 Suppl 1:9-13. doi: 10.1111/j.1365-4362.1992.tb04006.x.
It would be useful to have a safe, reliable, reproducible, and inexpensive human test model to determine the potency of topical corticosteroids and the bioequivalence of generic agents. Existing human test systems include erythema or inflammation induced by irritants or other stimuli, experimentally induced cutaneous disease-like states, and bioassays in patients with psoriasis. None of these systems is currently reliable enough to warrant general use. Among the shortcomings of existing test systems are the difficulty of producing a uniform, steroid-responsive test condition, the requirement to use occlusion in several of the systems, and the lack of agreement among the results of different tests. Despite these shortcomings, some of the tests may prove useful in comparing innovator and generic topical corticosteroids and in screening the potency of new agents.
拥有一个安全、可靠、可重复且廉价的人体测试模型来确定局部用皮质类固醇的效力以及仿制药的生物等效性将非常有用。现有的人体测试系统包括由刺激物或其他刺激引起的红斑或炎症、实验诱导的类皮肤病状态以及银屑病患者的生物测定。目前这些系统中没有一个足够可靠到可以普遍使用。现有测试系统的缺点包括难以产生统一的、对类固醇有反应的测试条件、在几个系统中需要使用封闭以及不同测试结果之间缺乏一致性。尽管存在这些缺点，但其中一些测试可能在比较创新型和仿制药局部用皮质类固醇以及筛选新药物的效力方面被证明是有用的。
