新药研发技术 (罗智)BME52082023秋  
2023秋
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选课类别:专业任务 教学语言:中文
课程类别:专业核心课 开课单位:生物医学工程系
课程层次:研究生 获得学分:3.0
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课程简介(教工部数据)
创新药的研发涉及药物发现、临床前研究和临床试验等一系列流程,各类新兴技术能有效降低药物研发过程的技术门槛、开发周期和成本。本课程将介绍原料药、制剂的开发及临床试验过程中所应用到的技术手段,以及如何应用于药理、药效、药代动力学、安全性评价等方面的研究。针对药物发现环节,课程将着重介绍高通量、高内涵技术手段,结合生物医学工具,如蛋白质定向进化、DNA 编码化合物库、器官芯片等,以及人工智能等方法在靶点发现、化合物筛选等环节的应用。针对药物制剂环节,课程将针对不同新药类型,如小分子(包括PROTAC等)、生物大分子、疫苗等介绍相关制剂工艺前沿进展,如缓释制剂、注射及微创手段等。针对临床试验环节,课程将比较中美在药物批准方面的差异,以及临床试验设计、患者招募和临床试验数据处理方向的最新进展。


The development of innovative drugs involves a series of processes such as drug discovery, preclinical research, and clinical trials. Various emerging technologies can effectively reduce the technical threshold, development cycle, and cost of the drug development process. This course will introduce the technical means used in the development of raw materials, preparations, and clinical trials, and how they are applied in research in pharmacology, pharmacodynamics, pharmacokinetics, safety evaluation, and other aspects.Regarding the drug discovery process, the course will focus on introducing high-throughput and high-content techniques, combined with biomedical tools such as protein-directed evolution, DNA-encoded compound libraries, organ chips, and other methods for the discovery of targets and screening of compounds, including the use of artificial intelligence.Regarding the drug formulation process, the course will introduce advanced formulation processes for different types of new drugs, such as small molecules (including PROTACs), biologics, vaccines, etc., such as sustained-release formulations, injection and minimally invasive techniques.Regarding the clinical trial process, the course will compare the differences in drug approval between China and the United States, as well as the latest developments in clinical trial design, patient recruitment, and clinical trial data processing.
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罗智

生物医学工程系

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