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采用血管收缩试验对仿制药和商品名外用类固醇进行双盲对照比较。

A double-blind controlled comparison of generic and trade-name topical steroids using the vasoconstriction assay.

作者信息

Olsen E A

机构信息

Department of Medicine, Duke University Medical Center, Durham, NC 27710.

出版信息

Arch Dermatol. 1991 Feb;127(2):197-201.

PMID:1990984
Abstract

Six generic formulations of five topical steroids were compared for bioequivalence with their trade-name counterparts using an in vivo vasoconstriction assay. Two of six generic formulations were found to show significantly less vasoconstriction than the respective trade-name topical steroids. The issue of generic equivalence of topical steroids is discussed, with particular emphasis on the vagaries of the vasoconstriction assay.

摘要

使用体内血管收缩试验,比较了五种局部用类固醇的六种仿制药配方与其商品名对应物的生物等效性。发现六种仿制药配方中的两种与各自的商品名局部用类固醇相比,血管收缩作用明显较弱。本文讨论了局部用类固醇仿制药等效性的问题,特别强调了血管收缩试验的变幻莫测。

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