影响药物输送系统转换的因素:关注先进技术,生物障碍和监管挑战
Mervat Balash1, Hamza Boucetta1, Wei He2
1School of Pharmacy, China Pharmaceutical University, Nanjing 211198, China.
概括
将药物输送系统 (DDS) 转化为临床实践面临重大生物和非生物障碍. 克服这些挑战是开发癌症和复杂疾病新疗法的关键.
科学领域:
- 生物医学工程
- 纳米技术
- 制药科学
背景情况:
- 药物输送系统 (DDS) 的临床翻译仍然是治疗进步的一个重大挑战,特别是在癌症和复杂疾病方面.
- 生物和非生物因素阻碍了DDS在临床环境中的成功实施.
研究的目的:
- 批判性地审查影响DDS临床转换的因素.
- 阐明影响DDS性能和部位选择性的生物障碍 (免疫,生物相容性,瘤微环境) 和非生物障碍 (制造,监管事务).
- 突出新兴技术,如器官芯片和人工智能,以改善临床前测试和DDS设计.
主要方法:
- 对药物输送系统的现有研究进行文献审查和批判性分析.
- 对影响DDS翻译的生物和非生物障碍的概念阐明.
- 识别和讨论新兴技术及其潜在影响.
主要成果:
- 生物障碍,包括免疫反应,生物相容性和瘤微环境相互作用,显著影响DDS性能和向.
- 非生物障碍包括制造业扩大规模,不同市场 (美国,欧盟,中国) 的复杂监管环境以及早期监管参与的需要.
- 像器官芯片和人工智能这样的新兴技术为提高临床前测试准确性和优化DDS设计提供了有希望的解决方案.
结论:
- 解决生物和非生物障碍对于成功临床转换DDS至关重要.
- 战略性监管互动和采用创新技术对于加速DDS开发和治疗应用至关重要.
- 这一审查提供了克服当前挑战并促进DDS在治疗中的实际应用的观点.
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