Department of Drug Regulatory Affairs, BVDU Poona College of Pharmacy, Pune 411 038, Maharashtra, India.
Department of Drug Regulatory Affairs, BVDU Poona College of Pharmacy, Pune 411 038, Maharashtra, India; Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Hajipur 844 102, Bihar, India.
Drug Discov Today. 2023 Sep;28(9):103700. doi: 10.1016/j.drudis.2023.103700. Epub 2023 Jul 12.
Artificial intelligence (AI) refers to the ability of a computer to carry out tasks associated with human intelligence, including thinking, discovering, and learning from prior experience. AI can be integrated to simplify the complexity of pharmaceutical regulatory affairs. AI tools can be applied to automate regulatory processes such as administrative work, dossier filling, data extraction, auditing, the implementation of regulations, and quality management. AI creates process links and reduces complexity, resulting in a more efficient management system. Human-AI interaction opens up new opportunities in regulatory affairs. This article explores the potential role of AI in pharmaceutical regulatory affairs.
人工智能（AI）是指计算机执行与人类智能相关任务的能力，包括思考、发现和从以往经验中学习。人工智能可以整合以简化药物监管事务的复杂性。人工智能工具可应用于自动化监管流程，如行政工作、文件归档、数据提取、审计、法规执行和质量管理。人工智能创建流程链接并减少复杂性，从而提高更高效的管理系统。人机交互在监管事务中开辟了新的机会。本文探讨了人工智能在药物监管事务中的潜在作用。
