Statistical Evaluation Methods and Considerations of Bioequivalence Studies for Nasal Sprays and Nasal Aerosols
10.13748/j.cnki.issn1007-7693.20231945
- VernacularTitle:鼻用喷雾剂/气雾剂生物等效性评价及其统计学应用考量
- Author:
GENG Ying
1
;
LIAO Ping
2
;
DENG Yanping
3
;
WEI Ningyi
1
;
TAN Dejiang
1
;
YANG Quan
4
;
ZHOU Xuehai
5
;
XIE Shaofei
6
;
ZHU Rongdie
7
;
WANG Rui
8
;
CHEN Hua
1
;
CHEN Guiliang
2
Author Information
1. National Institutes for Food and Drug Control, Beijing 102629, China
2. Shanghai Center of Drug Evaluation and Inspection, Shanghai 201210, China
3. Fujian Medical University, Fouzhou 530122, China
4. China Novartis Institutes for Biomedical Research Co., Ltd., Shanghai 201203, China
5. Tianjin Pharmaceutical Da Ren Tang Group Corp., Ltd., Traditional Chinese Medicine Research Institute, Tianjin 300457, China
6. State Key Laboratory of Neurology and Oncology Drug Development, Jiangsu Simcere Pharmaceutical Co., Ltd., Nanjing 325035, China
7. Beijing Union Pharmaceutical Factory Ltd., Beijing 102629, China
8. SPH Sine Pharmaceutical Laboratories Co., Ltd., Shanghai 201206, China
- Publication Type:Journal Article
- Keywords:
nasal sprays;
nasal aerosols;
bioequivalence;
guidance;
guideline;
population bioequivalence;
statistics
- From:
Chinese Journal of Modern Applied Pharmacy
2023;40(20):2827-2837
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To systematically review the background of bioequivalence assessment of nasal sprays and nasal aerosols and the guiding considerations for the bioequivalence assessment of these complex drug-device combination products by regulatory authorities in the United States, the European Union(EU) and China. METHODS This article provided detailed explanations on the innovative weight of evidence assessment approach adopted by the US Food and Drug Administration(FDA), and the statistical rationale, methods and considerations for the bioequivalence assessment of nasal sprays and nasal aerosols. Using the calculation methods described in the draft guidance for budesonide inhalation suspension and the draft guidance for fluticasone nasal spray propionate issued by FDA, the statistical parameters of two-sided and one-sided population bioequivalence calculation were realized through R language programming, and pseudo-code for the population bioequivalence (PBE) calculation programs was provided. This article also presented a comprehensive review of published guidelines and summaries review principles of the EU and China for nasal sprays and nasal aerosols equivalence assessment. RESULTS & CONCLUSION Nasal sprays/nasal aerosols is the focus of innovative and generic drug development in recent years. This paper provided valuable considerations references for the research and development, quality control and bioequivalence evaluation of generic preparations of nasal sprays/nasal aerosols.
