加快过程开发和产品配方
Mauricio Futran1, Fernando Muzzio2, Bikash Chatterjee3
1Pharmaceutical Engineering Solutions, LLC, Westfield, NJ, USA. mfutran@gmail.com.
Pharmaceutical research
|May 2, 2024
概括
新技术和适应性开发可以加快药物批准时间表,改善患者获得药物和紧急治疗的机会. 合作和监管转变对于更快的药物开发至关重要.
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:
- 长时间的药物开发和批准过程推迟了患者获得新药的机会.
- 对公共卫生紧急情况的反应时间缓慢,需要新的治疗方法.
- 目前的药物配方和工艺开发面临着巨大的加速障碍.
研究的目的:
- 探索加速药物产品开发和批准时间表的机会.
- 识别阻碍更快药物开发的障碍,并提出解决方案.
- 通过使用新技术,分享克服发展障碍的观点.
主要方法:
- 分析了2023年1月NIPTE路径研讨会的讨论.
- 审查当前的产品配方和工艺开发.
- 识别先进的制造技术和适应性开发策略.
主要成果:
- 新技术为加速药物开发提供了潜在的解决方案.
- 先进制造和适应性开发是加速发展的关键策略.
- 监管过程中的范式转变是必要的.
结论:
- 加快药物开发需要技术创新和适应性战略.
- 监管机构,行业和学术界之间加强竞争前的合作是必不可少的.
- 需要一个共同的战略来克服药物开发和批准的障碍.
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