Progress and Enlightenment of FDA Regulatory Science Research on Nasal Preparations
10.13748/j.cnki.issn1007-7693.20231873
- VernacularTitle:美国FDA鼻用制剂监管科学研究进展及启示
- Author:
LIAO Ping
1
;
GE Yuanyuan
1
;
CAO Meng
1
;
ZHAO Lu
2
;
JIA Guoshu
3
;
ZHANG Jingchen
4
;
CHEN Guiliang
1
Author Information
1. 1. Shanghai Center for Drug Evaluation and Inspection, Shanghai 201210, China
2. 2. Center for Inspection of Gansu Drug Administration (Center for Vaccine Inspection of Gansu), Lanzhou 730030, China
3. 3. China Pharmaceutical University, Nanjing 211198, China
4. 4. Yangtze River Center for Drug Evaluation and Inspection of National Medical Products Administration, Shanghai 201210, China
- Publication Type:Journal Article
- Keywords:
nasal preparation / nasal delivery / FDA / regulatory science / weight of evidence method
- From:
Chinese Journal of Modern Applied Pharmacy
2023;40(20):2766-2773
- CountryChina
- Language:Chinese
-
Abstract:
Abstract: OBJECTIVE To introduce the scientific progress in the regulation of nasal preparations by the US Food and Drug Administration(FDA), and provide reference and inspiration for the development, manufacture, quality control and supervision of nasal preparations in China. METHODS Regulations and literature relevant to the nasal preparations were translated and collated, and research projects and latest developments of FDA regulatory science were introduced. The difficulties encountered in the development of nasal preparations and the future development direction were analyzed. RESULTS The main directions of FDA nasal regulatory science were to evaluate potential bioequivalence(BE) methods as an alternative to comparative clinical endpoint BE studies, to employ digital technology to establish computer models, to study the factors influencing nasal absorption, pharmacokinetics and pharmacodynamics characteristics, as well as pediatric drug use studies, nasal-brain delivery, and to develop new tools, new methods, and new standards. It provided a scientific basis for optimizing regulatory strategy and improving regulatory efficiency. CONCLUSION This article summarizes the latest research on the regulatory science of nasal preparation, provides a reference for the management personnel of regulatory agencies, and provides new ideas and new methods for improving the quality and efficiency of China's drug regulation and realizing international standards.
