人类基因组编辑竞赛：放宽监管标准以获取商业优势？
The Human Genome Editing Race: Loosening Regulatory Standards for Commercial Advantage?
机构信息
Institute for Transfusion Medicine and Gene Therapy, Medical Center - University of Freiburg, Freiburg, Germany & Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Division of Medical Biotechnology, Paul-Ehrlich-Institut, Langen, Germany.
出版信息
Trends Biotechnol. 2019 Feb;37(2):120-123. doi: 10.1016/j.tibtech.2018.06.005. Epub 2018 Jul 13.
Medicinal products based on genome editing must undergo rigorous preclinical testing and are subject to regulatory oversight for proper risk assessment prior to first evaluation in humans. We give a European perspective on the regulatory expectations to translate genome editing to the clinic to ensure their timely progress to market.
基于基因组编辑的药物必须经过严格的临床前测试，并在首次人体评估前接受监管审查，以进行适当的风险评估。我们从欧洲的角度出发，阐述了将基因组编辑转化为临床应用的监管期望，以确保其及时推向市场。
Zotero 插件