新兴制药市场的创新悖论:可持续发展的障碍和机遇
Frederico Severino Martins1,2, Sivacharan Kollipara3, Praveen Sivadasu3
1Simulations Plus, Inc., Lancaster, CA, 93534, USA. Fredseverinomartins@gmail.com.
Pharmaceutical research
|May 29, 2025
概括
新兴市场可以通过采用先进技术来促进药物创新,例如基于生理学上的药物动力学 (PBPK) 建模和人工智能 (AI). 这些工具降低了成本,加速了市场进入,提高了全球竞争力和患者获得药物的机会.
科学领域:
- 制药科学 制药科学
- 药物开发 药物开发
- 新兴市场的新兴市场.
背景情况:
- 新兴制药市场 (巴西,印度,中国) 显示出增长,但专注于仿制药而不是创新.
- 挑战包括分散的法规,有限的基础设施,低的研发预算和API进口依赖.
- 新兴市场的研发投资 (收入≤5%) 落后于已建立的市场 (20%),扩大了创新差距.
研究的目的:
- 探索先进技术如何克服新兴市场中药物创新的障碍.
- 为制药公司展示采用创新工具带来的财务和运营效益.
- 评估这些技术在改善全球竞争力和药物获取方面的潜力.
主要方法:
- 审查新兴制药市场面临的挑战.
- 分析先进技术:基于生理学的药理动力学 (PBPK) 建模,人工智能 (AI),虚拟生物等价性研究.
- 使用PBPK建模的通用donepezil的案例研究.
主要成果:
- 基于生理学的药理动力学 (PBPK) 建模,人工智能和虚拟生物等价性研究简化了开发并降低了成本.
- 一个案例研究表明,PBPK模型投资的回报率为113.7% (在临床研究中) 到1.120% (在生物豁免中).
- 采用先进的工具可以更快地进入市场,扩展性,并与全球监管趋势保持一致.
结论:
- 先进技术为新兴市场提供了一条途径,可以弥合创新差距并提高全球竞争力.
- 实施像PBPK建模这样的工具可以提高资源效率,可持续性和获得负担得起的药物的机会.
- 接受技术创新对于新兴市场实现经济增长和制药行业的领导地位至关重要.
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