体外膜氧合(extracorporeal membrane oxygenation,ECMO)作为体外生命支持(extracorporeal life support,ECLS)技术的一种,用于部分或完全替代患者心肺功能,目前已得到广泛应用。在该产品的研发过程中,由于血液保存时间限制等原因,需要...体外膜氧合(extracorporeal membrane oxygenation,ECMO)作为体外生命支持(extracorporeal life support,ECLS)技术的一种,用于部分或完全替代患者心肺功能,目前已得到广泛应用。在该产品的研发过程中,由于血液保存时间限制等原因,需要通过动物试验进行必要的产品性能验证和安全性评估,为临床试验设计提供参考,也可进一步降低临床试验受试者及使用者的风险。为此本文参考相关监管机构发布的体外膜氧合产品动物试验研究的指南性文件、临床及非临床文献、临床操作共识等资料,给出针对ECMO产品进行动物试验研究的要点,以期为相关产品的开发、研制等提供参考。在对ECMO产品性能进行动物试验研究时,要考虑动物种类及模型、对照产品的选择、评价指标的选择、观察时间、样本量、操作要求等。对ECMO产品进行规范、科学、合理的动物试验验证可以通过尽可能少的成本获得更高质量的证据,更好地促进相关产品研制。展开更多
“Encourage and support the use of modern science and technology in the cosmetics R&D,with the help of China’s traditional advantage projects and special plant resources”.This is a clear voice in the Regulation ...“Encourage and support the use of modern science and technology in the cosmetics R&D,with the help of China’s traditional advantage projects and special plant resources”.This is a clear voice in the Regulation on the Supervision and Administration of Cosmetics often quoted as the evidence that China’s special plant resources are highly recommended by the country and enjoy a good external development environment.The Work Plan for Stabilizing the Growth of Light Industry(2023-2024),jointly issued by the Ministry of Industry and Information Technology,the National Development and Reform Commission and the Ministry of Commerce,also advocates“strengthening the development and innovation of special plant ingredients,promoting the scale production of bioactive ingredients,and extending the application of special plant ingredients in the food,cosmetics and other industries”.展开更多
文摘体外膜氧合(extracorporeal membrane oxygenation,ECMO)作为体外生命支持(extracorporeal life support,ECLS)技术的一种,用于部分或完全替代患者心肺功能,目前已得到广泛应用。在该产品的研发过程中,由于血液保存时间限制等原因,需要通过动物试验进行必要的产品性能验证和安全性评估,为临床试验设计提供参考,也可进一步降低临床试验受试者及使用者的风险。为此本文参考相关监管机构发布的体外膜氧合产品动物试验研究的指南性文件、临床及非临床文献、临床操作共识等资料,给出针对ECMO产品进行动物试验研究的要点,以期为相关产品的开发、研制等提供参考。在对ECMO产品性能进行动物试验研究时,要考虑动物种类及模型、对照产品的选择、评价指标的选择、观察时间、样本量、操作要求等。对ECMO产品进行规范、科学、合理的动物试验验证可以通过尽可能少的成本获得更高质量的证据,更好地促进相关产品研制。
文摘“Encourage and support the use of modern science and technology in the cosmetics R&D,with the help of China’s traditional advantage projects and special plant resources”.This is a clear voice in the Regulation on the Supervision and Administration of Cosmetics often quoted as the evidence that China’s special plant resources are highly recommended by the country and enjoy a good external development environment.The Work Plan for Stabilizing the Growth of Light Industry(2023-2024),jointly issued by the Ministry of Industry and Information Technology,the National Development and Reform Commission and the Ministry of Commerce,also advocates“strengthening the development and innovation of special plant ingredients,promoting the scale production of bioactive ingredients,and extending the application of special plant ingredients in the food,cosmetics and other industries”.