| 曹萌,葛渊源,张景辰,陈桂良.药物分析新技术在药品科学监管中的应用[J].中国药事,2021,35(6):614-623 |
| 药物分析新技术在药品科学监管中的应用 |
| Application of Drug Analysis Innovative Technology in Drug Scientific Regulations |
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| DOI：10.16153/j.1002-7777.2021.06.002 |
| 中文关键词: 药物分析 药品安全 风险防控 监管科学创新 数字化质量保证 |
| 英文关键词: drug analysis drug safety risk prevention and control regulatory scientific innovation digital quality assurance |
| 基金项目: |
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| 摘要点击次数: 1176 |
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| 中文摘要: |
| 目的：从数字化、自动化的药物分析技术角度探讨药品质量风险防控相关科学研究进展和应用前景。方法：通过案例分析和文献分析，回顾近年来的药害事件，介绍创新药物分析技术在药品全生命周期数据可靠性方面的应用，展望创新药物分析技术和理念对科学监管的发展推动。结果：药害事件大多数情况能归因为技术原因或人为故意，基于数字化、自动化的创新药物分析技术可在药品风险防控中发挥重要作用，并提升实验室数据可靠性。结论：直接反映药品质量属性的药物分析学领域科学监管亟待开展创新，需要充分发展运用数字化、自动化的现代技术手段，整合多学科的新技术提升质量保证能力，此外，监管决策也需要向智能化发展。 |
| 英文摘要: |
| Objective: The research progress and application prospects of risk prevention and control of drug quality were discussed from the perspective of digital and automatic drug analysis technology. Methods: Through case analysis and literature analysis, this article reviews drug hazard events in recent years, introduces the application of innovative drug analysis technology in the reliability of drug life cycle data, and looks into the future of the development of innovative drug analysis technology and concept in scientific regulations. Results: Drug hazard events are often caused by technical problems or artificial interference. Innovative drug analysis technology based on digitization and automation could play an important role in drug risk prevention and control, and it could improve the reliability of laboratory data. Conclusion: Such scientific fields as pharmaceutical analysis that directly reflects the quality attributes of drugs need innovation urgently. Digitization and automation that can integrate new multidisciplinary technologies are needed to improve quality assurance. In addition, the regulatory decision-making also needs to be intelligence-oriented. |
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