Key factors for subject management in bioequivalence trials of orally inhaled drug products
10.13699/j.cnki.1001-6821.2024.09.025
- VernacularTitle:吸入制剂生物等效性试验中受试者管理的关键要素
- Author:
Jing-Jing WANG
1
;
Jing ZHANG
;
Qiong WEI
;
Yu-Ran CAO
Author Information
1. 复旦大学附属华山医院临床药理研究中心,上海 200040
- Keywords:
orally inhaled drug products;
bioequivalence trial;
subject management
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(9):1360-1362
- CountryChina
- Language:Chinese
-
Abstract:
Due to the unique characteristics and complexity of administration of orally inhaled drug products,bioequivalence trial for orally inhaled generic drugs presents greater challenges in clinical implementation compared to conventional oral administration.This difficulty is particularly evident inmainly attributed to the variability during the self-administration inhalation of inhaled drugss by subjects.Therefore,effective management of subjects is crucial in clinical trials involving orally inhaled products.This paper,based on the experience in conducting bioequivalence trials for orally inhaled drug products,discusses key factors and measures for successful subject management in clinical trials.The aim is to enhance the clinical implementation capabilities of researchers in the evaluation of generic consistency for inhaled drug products and to ensure the quality of clinical trials.
