EMA和FDA药物相互作用指南的比较:概述

S. Janković
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引用次数: 2

摘要

2013年,欧盟和美国的监管机构几乎同时发布了新版行业指南,用于药品-药品和药品-食品相互作用开发过程中的药物检测要求。也就是说,这两个指导方针所设置的需求存在显著差异,本文的目的就是指出这些差异。在这篇综述中,作者仔细而全面地比较了美国食品药品监督管理局(FDA)和欧洲药品管理局(EMA)官方网站上公开发布的指南,强调了两套指南之间的差异。与FDA提供的指南不同,EMA指南缺乏测试与治疗蛋白相互作用以及药效学终点使用的固定要求。它也没有为在产品特性总结中使用“无交互”声明设定标准。另一方面,FDA目前缺乏关于检测药物-食品相互作用、使用相对诱导评分相关方法、证明存在可逆抑制和基于机制的失活的指导。值得注意的是,虽然FDA和EMA的药物相互作用指南的要求存在差异,但它们并不重要,并且主要与标准集的要求范围和准确性有关。
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Comparison of EMA and FDA guidelines for drug interactions: An overview
Abstract In 2013, the regulatory authorities of the European Union and the US issued, almost simultaneously, new editions of the industry guidelines for the requirements of drug testing during their development for drug–drug and drug–food interactions. That being said, there are significant differences in the requirements set by both guidelines, and the aim of this article is to point out those differences. In this review, the author carefully and comprehensively compared the publicly available guidelines via the official Food and Drug Administation’s (FDA) and European Medicine Agency’s (EMA) websites, highlighting the differences between the two sets. Unlike the guidelines provided by the FDA, the EMA guidelines lack set requirements for testing interactions with therapeutic proteins as well as with the usage of pharmacodynamics end-points. It also does not set standards for the use of the ‘no interaction’ declaration in the summary of product characteristics. On the other hand, the FDA currently lacks guidance for testing drug–food interactions, the use of the Relative Induction Score correlation method, and proving existence of reversible inhibition and mechanism-based inactivation. It is important to note that, while there are differences in the requirements for the FDA’s and the EMA’s drug interaction guidelines, they are not substantial and are mostly relating to the scope of requirements and precision of the standards set.
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