探索性新药临床试验的回顾与展望

Retrospect and prospect of exploratory new drug clinical trials

基于创新药物研发成本-效益风险的控制诉求,除了一种以早期获得人体PK/ADME信息以及高效筛选先导化合物为目的药物研发的新方法(也被称为0期临床试验/探索性临床试验),国内外亦开展了一些利用0期临床试验方法的研究,为探讨0期临床试验作为一种新的药物研发技术在实际应用的可行性提供了参考。

Based on innovative drug research cost-benefit risk control demands. Except an early human PK/ADME information and efficient new method for screening lead compounds for the purpose of drug development,also known as the 0 phase of clinical trial/exploratory clinical trials. At domestic and abroad has carried out some study conducted by 0 phase of clinical trial method,and to explore 0 phase of clinical trials as a new drug research and development technology in the reference for the feasibility of practical application.