Analysis of FDA's Product-specific Guidances for Nasal Preparations
10.13748/j.cnki.issn1007-7693.20231877
- VernacularTitle:美国FDA鼻用制剂相关个药指导原则汇总分析
- Author:
LIAO Ping
1
;
GENG Ying
2
Author Information
1. Shanghai Center for Drug Evaluation and Inspection, Shanghai 201210, China
2. National Institute for Food and Drug Control, Beijing 102629, China
- Publication Type:Journal Article
- Keywords:
nasal preparation;
FDA;
product-specific guidances;
in vitro bioequivalence;
comparative clinical endpoint bioequivalence
- From:
Chinese Journal of Modern Applied Pharmacy
2023;40(20):2786-2793
- CountryChina
- Language:Chinese
-
Abstract:
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.
