【摘要】 局部用药制剂呈现多样化的趋势,其命名和等效性评价成为科学评价和规范局部用制剂的重要方面。本文探讨了局部用制剂的命名的现状,分析了局部用制剂的命名依据及方法。比较了国内外在局部用制剂生物等效性评价方面的异同和差距,分析了采用皮肤药物动力学研究局部用制剂生物等效性的方法和注意事项,提出了建立局部用制剂生物等效性评价研究技术指南的必要性。更多还原

【Abstract】 Topical preparations develop diversely and the nomenclature and bioequivalence evaluation become to the important parts of the scientific evaluation and the standardization of topical preparations.This article discussed the current nomenclature of topical preparations and analyzed the nomenclature principle and methods of topical preparations.The difference in bioequivalence evaluation of topical preparations between dom and abroad was compared,the research method with Dermatopharmacokinetics and warnings were analyzed,and the necessity to establish the guidelines was proposed.更多还原