规范人工智能支持的人类治疗生态系统.
Rominder Singh1, Mark Paxton2, Jared Auclair3
1Professor of Practice, Regulatory Sciences & AI, Northeastern University, Boston, MA, 02115, USA. rom.singh@northeastern.edu.
Communications medicine
|May 17, 2025
概括
人工智能 (AI) 可以改变药物开发,但有效的监管是关键. 本视角探讨了对生物制药行业AI监管的挑战和建议.
科学领域:
- 生物制药行业 生物制药行业
- 药物的发现和开发.
- 监管科学是一种监管科学.
背景情况:
- 人工智能 (AI) 为制药创新提供了变革性的潜力.
- 生物制药行业需要严格监管药品质量,疗效和安全.
研究的目的:
- 检查药物发现和开发中规范人工智能驱动技术的挑战.
- 为生物制药行业的人工智能提供有效监管框架的建议.
主要方法:
- 对当前全球药物监管实践的评估.
- 识别人工智能监管中的空白和未知因素.
- 分析AI在药物发现,开发,制造和交付中的作用.
主要成果:
- 人工智能将对制药研发时间表和成本产生重大影响.
- 有效的监管对于利用人工智能的好处,同时确保安全至关重要.
- 现有的监管框架可能需要适应人工智能驱动的创新.
结论:
- 焦点应该是如何监管药品中的AI,而不是如果.
- 解决监管差距对于促进人工智能创新至关重要.
- 需要积极的监管策略来支持生物制药行业的AI.
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