中国临床药理学杂志2018,Vol.34Issue(5):584-588,5.DOI:10.13699/j.cnki.1001-6821.2018.05.027
在药物早期临床研究中加速器质谱的应用研究现状
Recent advances of accelerator mass spectrometry in clinical drug development
摘要
Abstract
Accelerator mass spectrometry (AMS) is a sensitive isotope ratio technique used in drug development that allows for small levels of 14C-drug to be administered to humans,thereby removing regulatory hurdles associated with radiotracer studies.It has facilitated the adoption of a human microdosing and microtracer studies in the early phase of clinical drug development.Studies using AMS and labeled compounds can provide pharmacokinetic and metabolism data,including:fundamental pharmacokinetics (clearance rate and apparent distribution volume),absolute bioavailability,mass balance,routes and rates of excretion,metabolic fat.This review focuses on the advance progress of AMS as well as its roles in the early phase of clinical drug development.关键词
加速器质谱/药物临床研究/药代动力学Key words
accelerator mass spectrometry/clinical drug development/pharmacokinetics分类
医药卫生引用本文复制引用
王少媛,郑昕,胡蓓,江骥..在药物早期临床研究中加速器质谱的应用研究现状[J].中国临床药理学杂志,2018,34(5):584-588,5.基金项目
国家“十三五”重大新药创制专项基金资助项目(2017ZX09304031-001) (2017ZX09304031-001)
国家自然科学基金青年基金资助项目(81503164) (81503164)