美国FDA鼻用制剂相关个药指导原则汇总分析

目的 通过梳理美国食品药品监督管理局（Food and Drug Administration，FDA）发布的鼻用制剂相关个药指导原则，总结FDA对鼻用制剂仿制药的研究要求，为国内鼻用制剂仿制药开发和评价提供参考。方法 在FDA官网发布的个药指导原则中筛选出鼻用制剂相关指导原则，进行汇总分析。结果 目前FDA现行43个鼻用制剂相关个药指导原则，推荐的生物等效性方法包括体外生物等效性研究、药动学研究、比较临床终点研究方法等，因不同品种而有所区别。部分个药指导原则已收录先进的体外检测技术如形态定向拉曼光谱用于代替体内临床试验。本文对不同种类生物等效性试验的试验设计、主要研究终点和等效性标准方面进行了代表性描述。结论 本文对FDA发布的鼻用制剂相关个药指导原则进行了汇总分析，为国内鼻用制剂仿制药开发和评价提供参考。

Analysis of FDA's Product-specific Guidances for Nasal Preparations

OBJECTIVE To summarize the research requirements of Food and Drug Administration(FDA) on generic drugs of nasal preparations by reviewing product-specific guidances for nasal preparations issued by FDA, and to provide reference for the development and evaluation of generic drugs of nasal preparations in China. METHODS The relevant product-specific guidances of nasal preparations were selected from FDA''s official website and summarized and analyzed. RESULTS There were currently 43 FDA product-specific guidances for nasal preparations. The recommended bioequivalence methods include in vitro bioequivalence studies, pharmacokinetic studies, comparative clinical endpoint studies, etc., which vary according to different drugs. Some of the product-specific guidances had included advanced in vitro detection techniques such as morphology-directed Raman spectroscopy(MDRS) in place of in vivo clinical trials. In this paper, the experimental design, main study endpoint and equivalence criteria of different types of bioequivalence tests were described. CONCLUSION This paper summarizes and analyzes the related product-specific guidances of nasal preparations issued by FDA, and provides reference for the development and evaluation of generic nasal formulations in China.