对我国药物临床前研究实验室管理的思考

Thinking about the Management of Preclinical Drug Research Laboratory in China

目的对我国药物临床前研究实验室管理现状进行研究,完善药物研发监管体系。方法采用问卷调研、实地调研和文献比对等方法。结果与结论制定药物临床前研究实验室管理规范,是加强药物研究监管的重要基础工作,对保证药品质量具有重要意义。

Objective Researching the management status of laboratory on the preclinical studies of drugs,to improve the regulatory system of drug research and development.Methods To analysis by survey research,field research,literature comparison and other forms.Results and Conclusion The development of preclinical drug research laboratory practice is the important basic work,to strengthen the supervision of drug research and to ensure drug quality.