通过基于模型的药物开发来缓解日本的药物损失
Yasuhiko Imai1, Emi Akatsu1, Suzanne K Minton2
1Certara GK, Tokyo, Japan.
CPT: pharmacometrics & systems pharmacology
|October 12, 2025
概括
在日本,批准药物在当地无法获得的药物损失可以减少. 使用模型信息化药物开发 (MIDD) 与AI/ML的战略方法可以改善患者获得重要治疗的机会.
科学领域:
- 制药科学 制药科学
- 药物开发 药物开发
- 监管科学 监管科学
背景情况:
- 在日本",药物损失"是指缺乏本地开发或批准的已批准药物.
- 这种现象限制了患者获得潜在有益治疗的机会.
研究的目的:
- 探索在日本最大限度地减少'药物损失'的战略.
- 突出模型信息化药物开发 (MIDD) 和AI/ML在解决这个问题的作用.
主要方法:
- 审查目前在日本的药物开发和批准过程.
- 分析人工智能/机器学习 (AI/ML) 增强的MIDD策略的潜力.
主要成果:
- 一个全面的MIDD战略,增强AI/ML,可以显著减少"药物损失"的情况.
- 这种方法简化了开发和批准的途径.
结论:
- 与AI/ML一起实施先进的MIDD对于最小化日本的"药物损失"至关重要.
- 制药行业与监管机构之间的持续合作对于患者获取和全球进步至关重要.
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