王璐;王景浩;
GuangDong Pharmaceutical Association;

• 1:广东省药学会
• 2:暨南大学附属第一医院

摘要(Abstract)：

<正>1 背景新药研发的传统模式是通过大量的体外试验获取临床前数据,在此基础上向药品监管部门提出新药临床试验(investigational new drug, IND)申请,经批准后进入临床试验阶段[1]。药物的临床试验一般分为Ⅰ至Ⅳ期[2],其中Ⅰ期临床试验是在健康人群或患者中(20～80名受试者)进行的测试,旨在初步确定剂量、评估药物的安全性;Ⅱ期临床试验是对更大的群体(100～300名受试者)进行试验,

关键词(KeyWords)： 正电子发射断层扫描;放射性配体;0期临床试验;微剂量;放射性药品使用许可证(Ⅳ类)
PET;radioligand;phase 0 clinical trials;microdosing;License for Use of Radiopharmaceuticals(level Ⅳ)

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 王璐;王景浩;
GuangDong Pharmaceutical Association;

Email:

DOI:

参考文献(References)：

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