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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。
Accelerating the development of new drugs with our country’s intellectual property rights is the only way after China’s accession to the World Trade Organization (WTO). It is one of the key factors to determine whether a new drug can enter the market by predicting the possibility of the new drug being marketed as being harmful to human health and providing a scientific basis for the potential impact of a new drug on human health. One of the most important basic work is the detection and study of toxicological pathology. At present, we must pragmatically seek new ideas on the basis of traditional toxicological pathology. While establishing a systematic and standardized standard system of toxicological pathology, we should focus our attention on fast and new words, focusing on immunotoxicity Evaluation of the new trends, the establishment of a new rapid replacement model, the introduction of new modern molecular biology techniques to conduct in-depth toxicological research. We should also establish a toxicity evaluation system in the high-throughput screening system of innovative drugs in order to advance the evaluation of drug safety from the pre-clinical stage to the drug discovery stage.