Aquilonius Sten-Magnus, Nyholm Dag
a Department of Neuroscience , Neurology, Uppsala University , Uppsala , Sweden.
Ups J Med Sci. 2017 Jun;122(2):71-77. doi: 10.1080/03009734.2017.1285374. Epub 2017 Mar 3.
This review will illustrate the process of moving from an idea through preclinical research and Galenic developments into clinical investigations and finally to approval by regulatory agencies within the European Union. The two new treatment strategies described, levodopa/carbidopa intestinal gel and levodopa/carbidopa microtablets, for advanced Parkinson's disease, have been developed in collaborative research within departments at Uppsala University. With this historical approach, reference priority is given to reports considered to be of special importance for this more than two decades long process 'from bedside to bench to bedside'.
本综述将阐述从一个想法开始，历经临床前研究、盖伦制剂研发、进入临床研究，最终获得欧盟监管机构批准的过程。所描述的两种用于晚期帕金森病的新治疗策略，即左旋多巴/卡比多巴肠凝胶和左旋多巴/卡比多巴微片，是由乌普萨拉大学各部门合作研究开发的。采用这种历史视角，对于这个长达二十多年“从床边到实验台再回到床边”的过程中被认为具有特别重要意义的报告给予了优先参考。
