正电子发射断层显像技术在药物开发0期临床研究中的应用

Positron Emission Tomography(PET)Application in the Phase 0 Clinical Trials in Drug Development

新药研发是一个耗时长且风险高的过程,需要大量资源的投入。“0期临床研究”(phase 0 clinical trails)的主要目的是通过“微剂量”研究快速获得人体药代动力学及药效学等重要信息,为后期的药物临床研究及开发节约资源。正电子发射断层显像(positron emission tomography,PET)是一种非侵入性的分子显像技术,仅需注射极低化学计量的放射性示踪剂即可获取关于候选药物及其对应生物靶点在分子水平的定量信息。该技术可快速应用于人体,加速药物开发过程,减少开发风险。目前,已经有不少的新药研发试验使用了这项技术,我国尚在起步阶段。本文将对PET在药物开发0期临床研究中的应用进行简要介绍。

Drug development is a time-consuming and high-risk process that requires numerous resources. The main purpose of "phase 0 clinical trials" is to obtain the pharmacokinetics and pharmacodynamics information of candidates in human through " microdose" research,saving resources for further phase Ⅰ to Ⅲ clinical testing. Positron emission tomography (PET) is a non-invasive molecular imaging technology that requires trace amount of radioligand to provide in vivo quantitative information of the candidates and the corresponding biomarkers at a molecular level,thus accelerating drug clinical translation and reducing development risks. Nowadays,PET has been widely used in the process of drug development,however,phase 0 study by PET is still in its infancy in China. This article will briefly introduce the application of PET in phase 0 clinical trials in drug development.