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.