Recent advances of accelerator mass spectrometry in clinical drug development
10.13699/j.cnki.1001-6821.2018.05.027
- VernacularTitle:在药物早期临床研究中加速器质谱的应用研究现状
- Author:
Shao-Yuan WANG
1
;
Xin ZHENG
;
Bei HU
;
Ji JIANG
Author Information
1. 北京协和医院临床药理中心
- Keywords:
accelerator mass spectrometry;
clinical drug development;
pharmacokinetics
- From:
The Chinese Journal of Clinical Pharmacology
2018;34(5):584-588
- CountryChina
- Language:Chinese
-
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.