Ⅰ期临床试验受试者用药的关键步骤探讨

Tian-ao CHEN,Yan LIANG,Xiao-yan SHENG,Ran XIE,Nan ZHAO,Xia ZHAO,Yi-min CUI,Chang-qing YANG

The Chinese Journal of Clinical Pharmacology（2018）

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Abstract

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.

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