摘要
标准化的受试者管理是确保受试者安全和试验结果科学可信的基础。本文从Ⅰ期临床试验过程中健康受试者管理出现的一些问题出发,结合具体工作经验,探讨健康受试者管理的措施,提高受试者管理效率以及Ⅰ期药物临床试验质量。
Standardized subjects management is the basis to ensure the safety of subjects and the scientific credibility of trial results. Based on the work experience of Phase Ⅰ Unit of Peking University First Hospital,we discussed some problems and measures of healthy subjects management to improve the efficiency of healthy volunteers management and the quality of phase Ⅰ drug clinical trials.
作者
盛晓燕
赵侠
崔一民
SHENG Xiao-yan;ZHAO Xia;CUI Yi-min(Department of Pharmacy,Peking University First Hospital,Beijing 100034,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2020年第18期2109-2112,共4页
Chinese Journal of New Drugs
关键词
Ⅰ期药物临床试验
健康受试者
问题
管理
phase Ⅰ drug clinical trial
healthy subjects
problems
management