论文部分内容阅读
近日,美国食品药品管理局(FDA)下属的科学咨询委员会对药品评价及研究中心(CDER)主任JanetWoodcock提出的“药物基因组学数据管理程序草案”进行了讨论。 通过药物基因组学数据,研究人员可以了解到患者的基因特点与其对药物的反应之间的联系。因此,某些制药公司希望利用这些信息,开发出一些针对患者的特定遗传特点来发挥作用的新药。不过,对大多数公司而言,他们目前更关注的是患者对药物代谢的能力与其发生药物毒性反应之间的关系。例如,在不良反应报告数目最多的27
Recently, the Scientific Advisory Committee of the United States Food and Drug Administration (FDA) discussed the “Drug Genomics Data Management Procedure” proposed by Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER). Through pharmacogenomic data, researchers can understand the relationship between the patient’s genetic characteristics and its response to drugs. Therefore, some pharmaceutical companies hope to use this information to develop new drugs that will work on the specific genetic features of patients. However, for most companies, they are currently more concerned with the relationship between patients’ ability to metabolize drugs and their occurrence of drug toxicity. For example, the number of adverse reaction reports is 27