Pfizer Worldwide Research & Development, La Jolla, California, Collegeville, Pennsylvania, and New York, New York, USA.
Takeda Pharmaceuticals International, Deerfield, Illinois, USA.
Clin Pharmacol Ther. 2016 Feb;99(2):198-207. doi: 10.1002/cpt.293. Epub 2015 Dec 19.
High throughput molecular and functional profiling of patients is a key driver of precision medicine. DNA and RNA characterization has been enabled at unprecedented cost and scale through rapid, disruptive progress in sequencing technology, but challenges persist in data management and interpretation. We analyze the state-of-the-art of large-scale unbiased sequencing in drug discovery and development, including technology, application, ethical, regulatory, policy and commercial considerations, and discuss issues of LUS implementation in clinical and regulatory practice.
高通量分子和功能患者分析是精准医学的关键驱动力。通过测序技术的快速颠覆性进展，以空前的成本和规模实现了 DNA 和 RNA 特征分析，但在数据管理和解释方面仍然存在挑战。我们分析了药物发现和开发中大规模无偏测序的最新技术，包括技术、应用、伦理、监管、政策和商业方面的考虑，并讨论了 LUS 在临床和监管实践中的实施问题。
