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Human Genome Editing in the Clinic: New Challenges in Regulatory Benefit-Risk Assessment.
Cell Stem Cell ( IF 19.8 ) Pub Date : 2017-10-05 , DOI: 10.1016/j.stem.2017.09.007
Mohamed Abou-El-Enein , Toni Cathomen , Zoltán Ivics , Carl H. June , Matthias Renner , Christian K. Schneider , Gerhard Bauer

As genome editing rapidly progresses toward the realization of its clinical promise, assessing the suitability of current tools and processes used for its benefit-risk assessment is critical. Although current regulations may initially provide an adequate regulatory framework, improvements are recommended to overcome several existing technology-based safety and efficacy issues.

中文翻译:

诊所中的人类基因组编辑:监管利益风险评估中的新挑战。

随着基因组编辑朝着实现其临床前景迅速发展,评估当前用于其利益风险评估的工具和过程的适用性至关重要。尽管当前的法规最初可能会提供适当的法规框架,但建议进行改进以克服一些现有的基于技术的安全性和有效性问题。
更新日期:2017-10-05
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