PFI-AIR:Industry-Academia Research Partnership for Developing & Implementing Non-Destructive Characterization and Assessment of Pharmaceutical Oral Dosages in Continuous Manufa

PFI-AIR：产学研合作促进发展

• 批准号: 1237873
• 负责人: Alberto Cuitino
• 金额: $ 80万
• 依托单位: Rutgers University New Brunswick
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-01 至 2015-04-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1237873&HistoricalAwards=false
• 关键词: PFI; AIR; Industry; Academia; Research

This NSF Accelerating Innovation Research (AIR) project will establish a public-private ecosystem for the development and implementation of innovative strategies for non-destructive characterization and assessment of pharmaceutical oral dosage forms targeted to continuous manufacturing processes. Non-destructive testing also impacts the quality of health-care treatment, circumventing the issues posed by destructive testing, in which dosages given to patients can never be tested. Non-destructive testing additionally can provide a foundation to better understand critical scientific issues such as within-patient and patient-to-patient response variability since the variability associated with the manufacturing process can be de-convoluted by this approach. Enabling non-destructive testing has significant economic impact on the quality and control of therapeutics. From an economic perspective, non-destructive testing can provide a pathway for advancing Real-Time Release Testing (RTRT), which has the potential to reduce manufacturing costs associated with large captive waiting-for-release inventories and failed batches. Moreover, non-destructive testing can provide a competitive edge for high-quality U.S.-based manufacturing by retaining and expanding U.S. manufacturing jobs in the pharmaceutical sector.

该NSF加速创新研究（AIR）项目将建立一个公私合作的生态系统，用于开发和实施针对连续生产工艺的药物口服剂型的非破坏性表征和评估的创新战略。 非破坏性检测还影响到医疗保健的质量，避免了破坏性检测带来的问题，因为在破坏性检测中，给患者的剂量永远无法检测。此外，无损检测还可以为更好地理解关键的科学问题提供基础，例如患者内和患者间的反应变异性，因为与制造过程相关的变异性可以通过这种方法去卷积。实现非破坏性测试对治疗的质量和控制具有显著的经济影响。 从经济的角度来看，无损检测可以为推进实时放行检测（RTRT）提供一条途径，这有可能降低与大型圈养等待放行库存和不合格批次相关的制造成本。此外，无损检测可以为高质量的美国产品提供竞争优势。通过保留和扩大美国制药业的制造业就业机会，