把毒性病理学研究提高到一个新水平

A DISCUSSION ON IMPROVEMENT OF TOXICOLOGICAL PATHOLOY STUDY

加速具有我国知识产权的新药的开发,是我国加入世界贸易组织(WTO)后的必由之路。预测上市新药对人类健康危害的可能,提供新药对人类健康可能产生影响的科学依据,是决定新药能否进入市场的关键因素之一。而其中最重要的基础工作,就是毒性病理学的检测和研究。当前,我们要在传统的毒性病理学研究的基础上务实求新,在建立系统的、规范的毒性病理学评价标准体系的同时,将眼光要放在快和新两个字上,注重免疫毒性评价的新动向,建立新的快速替代模型,引进新的现代分子生物学技术,以深入开展毒性机制的研究。我们还应该建立创新药物高通量筛选体系中的毒性评价体系,以便把药物安全性评价工作从临床前阶段提早到药物发现阶段来进行。

Toxicological pathology plays a key role in drug safely assessment. To enhance the research level of toxicologi-cal pathology, the following studies should be carried out urgently: setting up a standard operation procedure (SOP) for toxicological pathology assessment; emphasizing on irnmunotoxicology evaluation; adopting a new experiment model for replacement, featuring high speed and reliability; introducing new techniques and new methods in toxicological mechanism research; and establishing a new appraisal system to screen innovative drugs and rapid and high precision methods for early security assessment, detection and measurement.