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Abstract：
The approval of topical generic products is essentially governed by clinical endpoint studies. Is this the most efficient approach to document bioequivalence in these particular dosage forms? This issue has sparked multiple discussions among different stakeholders - academia, industry and several regulatory agencies - in the active pursuit for new and robust surrogate methodologies. This mini review attempts to critically discuss this topic in light of the recently issued European regulatory requirements within the proposed modular framework for bioequivalence assessment.
摘要：
外用仿制药的批准基本上取决于临床终点研究。这是在这些特定剂型中记录生物等效性的最有效方法吗？这个问题引发了不同利益相关者——学术界，行业和几个监管机构-积极追求新的和强大的替代方法。本小型审查试图根据最近发布的欧洲法规要求在拟议的生物等效性评估模块化框架内批判性地讨论这一主题。
