Study on the key steps for the subject medication of phase Ⅰ clinical trials
10.13699/j.cnki.1001-6821.2018.07.046
- VernacularTitle:Ⅰ期临床试验受试者用药的关键步骤探讨
- Author:
Tian-Ao CHEN
1
;
Yan LIANG
;
Xiao-Yan SHENG
;
Ran XIE
;
Nan ZHAO
;
Xia ZHAO
;
Yi-Min CUI
;
Chang-Qing YANG
Author Information
1. 中国药科大学基础医学与临床药学学院
- Keywords:
phase Ⅰ clinical trial;
subject medication;
key step
- From:
The Chinese Journal of Clinical Pharmacology
2018;34(7):893-897
- CountryChina
- Language:Chinese
-
Abstract:
Phase Ⅰ clinical trials are the preliminary tests of clinical pharmacology 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 appropriately,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,injection,inhalation and other delivery methods,to make sure the scientificity,accuracy and objectivity of the test results.This will also ensure the smooth development of late-stage clinical trials.
