Critical Path Institute, Tucson, Arizona, USA.
Pfizer, Groton, Connecticut, USA.
Clin Transl Sci. 2019 May;12(3):240-246. doi: 10.1111/cts.12619. Epub 2019 Mar 18.
The Critical Path for Parkinson's (CPP) Imaging Biomarker and Modeling and Simulation working groups aimed to achieve qualification opinion by the European Medicines Agency (EMA) Committee for Medical Products for Human Use (CHMP) for the use of baseline dopamine transporter neuroimaging for patient selection in early Parkinson's disease clinical trials. This paper describes the regulatory science strategy to achieve this goal. CPP is an international consortium of three Parkinson's charities and nine pharmaceutical partners, coordinated by the Critical Path Institute.
帕金森病（CPP）成像生物标志物和建模与仿真工作组的关键路径旨在通过欧洲药品管理局（EMA）人用医药产品委员会（CHMP）获得资格意见，以将基线多巴胺转运蛋白神经影像学用于早期帕金森病临床试验中的患者选择。本文介绍了实现这一目标的监管科学策略。CPP 是由三个帕金森病慈善机构和九个制药合作伙伴组成的国际联盟，由关键路径研究所协调。
