摘要
Ⅰ期临床试验是初步的临床药理学及人体安全性评价试验。因其以健康受试者为主,且受试者人数较少,所以对数据准确性的要求更高。如果受试者用药不够准确,将影响整个试验结果,无法对Ⅱ、Ⅲ期临床试验提供参考。因此,受试者用药是Ⅰ期临床试验的关键步骤之一。本文总结并探讨了口服、注射、吸入、透皮给药等不同给药方式的关键步骤,以期保证试验结果的科学性、准确性与客观性,进而保证后期临床试验的顺利开展。
Phase I clinical trials are the preliminary tests of clinical phar- macology and human safety evaluation. Majority of the subjects in phase I clinical trials are healthy subjects. Besides, there are only a few number of healthy subjects included in one trial. Thus the data requires better accuracy and responsibility. If the subjects do not take medicine appro- priately, it will directly affect the results and fail to provide accurate reference for the coming phase II、III clinical trial. Therefore subject medication is one of the key steps in the conduct of phase I clinical trial. This article summarizes and discusses the key steps for oral, injec- tion, inhalation and other delivery methods, to make sure the scientifici- ty, accuracy and objectivity of the test results. This will also ensure the smooth development of late - stage clinical trials.
作者
陈湉傲
梁雁
盛晓燕
解染
赵楠
赵侠
崔一民
杨长青
CHEN Tian -ao1＇2, LIANG Yan2, SHENG Xiao -yan2, XIE Ran, ZHAO Nan2, ZHAO Xia2, CUI Yi - rain2, YANG Chang - qing(1. School of Basic Medicine and Clinical Pha~ , ＇ China Pharmaceutical University, Nanjing 211198, China ; 2. Department of Pharmacy, The First Hospital, Peking University, Beijing 100034, Chin)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2018年第7期893-897,共5页
The Chinese Journal of Clinical Pharmacology
