从监管角度看支持新药开展临床试验的安全药理学研究的重要意义

摘要

我国制药企业研发新药的工作已形成一定态势.安全药理学研究是支持新药开展临床试验的一项不可或缺的研究内容.本文从监管角度阐述支持新药开展临床试验的安全药理学研究的意义,对该内容的深入了解将有助于研发者理解其在新药研发过程中的不可替代性,有助于研发者理解该研究的本质,从而在试验设计和综合分析各项研究结果时能具有宏观把握思维.%Research and development (R&D) of new drugs have been started in industry in China. Safety pharmacology study is a necessary issue before drug clinical trial. Here we talk about the regulatory perspective on the importance of safety pharmacology study before clinical trial of new drugs. Knowledge on this issue will help R&D investigators to understand the extreme importance of the safety pharmacology study, to comprehend its essential, and to perform macroscopic analysis when designing the study and analyzing experiment data.