在不成比例方法和人工智能集成的界面上的生物类似管理:当前的证据和潜在的战略
Ahmad Z Al Meslamani1, Anan S Jarab2, Eman Merghani Ali Mohammed3
1College of Pharmacy, Al Ain University, Abu Dhabi, United Arab Emirates.
Expert opinion on biological therapy
|February 11, 2026
概括
人工智能 (AI) 通过改进信号管理来增强生物类似药管理的传统药物监管 (PV). 人工智能工具增强了安全性,适当使用和价值跟踪,解决了不成比例方法的挑战.
科学领域:
- 药物监督和人工智能 药物监督和人工智能
- 生物相似的管理管理.
- 医疗信息学 医疗信息学
背景情况:
- 生物类似管理对于安全性,适当使用和价值至关重要,但在不成比例的方法中面临挑战.
- 传统的药监 (PV) 信号管理可以通过人工智能 (AI) 工具来增强.
- 人工智能提供"智能增强"策略,加强而不是取代现有的光伏系统.
研究的目的:
- 审查人工智能在生物类似药物监管中的作用.
- 确定人工智能应用,以提高生物类似药的安全性,适当使用和价值.
- 探索在生物类似光伏中人工智能实施的挑战和优先事项.
主要方法:
- 从2010年1月到2025年11月的证据映射的叙事审查.
- 在多个数据库 (PubMed/MEDLINE,Embase,Scopus,Web of Science,Cochrane) 和灰色文献来源中进行了搜索.
- 关于生物仿制剂特异性PV,切换,实施和价值跟踪的优先证据,补充了一般PV/AI文献.
主要成果:
- 近期的人工智能部署 (NLP,规范化,脱重复,排名) 可以提高案例完整性,可追溯性和分类.
- 中期优先事项包括联合分析,外部验证和人工智能模型的可转移性.
- 持续存在的瓶,如阶级不平衡和词汇映射,需要监测和标准评估.
结论:
- 人工智能工具可以显著提高生物类似药物的药物监管和管理.
- 人工智能的运营实施需要解决数据挑战并建立治理.
- 未来的AI整合旨在为生物类似药物提供更强大,更可靠的光伏系统.
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