在鼻喷雾剂新药Ⅰ期临床研究中开展精准化临床管理的探讨  

Exploration on Precise Clinical Management in Phase Ⅰ Clinical Trials of New Nasal Sprays

作　　者：刘敏 储楠楠 黄凯 LIU Min;CHU Nannan;HUANG Kai(The Affiliated Wuxi People's Hospital of Nanjing Medical University,Phase Ⅰ Clinical Research Center of Drug Clinical Trial Institution,Wuxi Jiangsu 214023,China)

机构地区：[1]南京医科大学附属无锡人民医院,药物临床试验机构Ⅰ期临床研究中心,江苏无锡214023

出　　处：《药品评价》2023年第7期788-792,共5页Drug Evaluation

摘　　要：目的探讨如何开展鼻喷雾剂新药Ⅰ期临床研究的精准化临床管理。方法对培训管理、病房管理、动态心电图采集管理、受试者鼻腔管理、血样采集管理、心理教育管理六个方面的工作进行总结。结果形成了一套较为完善的针对鼻喷雾剂新药Ⅰ期临床试验的精准化临床管理模式。结论该研究成果为我国鼻喷雾剂新药Ⅰ期临床研究的精准化管理提供参考,全面提升临床试验质量。Objective To explore how to carry out the accurate clinical management of the phase Ⅰ clinical study of nasal spray.Methods The work was summarized from six aspects:training management,ward management,Holter collection management,subjects'nasal management,blood sample collection management,and psychoeducational management.Results A relatively perfect precise clinical management mode for the phase Ⅰ clinical trials of new nasal sprays was formed.Conclusion It provides reference for the accurate implementation of phase Ⅰ clinical research of nasal spray in China,and improves the quality of clinical trials in an all-round way.

关 键 词：鼻用喷雾剂 Ⅰ期临床试验 精准临床管理 

分 类 号：R95[医药卫生—药学]