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Challenges of Using Closed System Transfer Devices With Biological Drug Products: An Industry Perspective

机译：使用生物药品使用封闭式系统转移装置的挑战：行业视角

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Alavattam Sreedhara; Camellia Zamiri; Sumit Goswami; Sarah Weiser; Michael Cram; Twinkle R. Christian; Bharat Jagannathan;
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年度 2020
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1. Challenges in the Development of Drug/Device and Biologic/Device Combination Products in the United States and European Union: A Summary From the 2013 DIA Meeting on Combination Products [J] . Tsourounis Marilyn, Stuart Jeffrey, Smith MaryAnn, Therapeutic innovation & regulatory science. . 2015,第2期

机译：美国和欧盟在药品/器械和生物/器械组合产品开发方面的挑战：2013 DIA组合产品会议摘要
2. How can the use of closed system transfer devices to facilitate sharing of drug vials be optimised to achieve maximum cost savings? [J] . Gilbar Peter J., Chambers Carole R., Vandenbrouche Johan, Journal of oncology pharmacy practice: official publication of the International Society of Oncology Pharmacy Practitioners . 2019,第1期

机译：如何使用封闭的系统转移装置来促进药物小瓶的共享优化，以实现最高成本节省？
3. Application of the 2015 proposed NIOSH vapor containment performance protocol for closed system transfer devices used during pharmacy compounding and administration of hazardous drugs [J] . Forshay Charlotte M., Streeter Shawn O., Salch Stephanie A., Journal of oncology pharmacy practice: official publication of the International Society of Oncology Pharmacy Practitioners . 2019,第5期

机译：2015年建议的山核型蒸汽储能性能方案用于药房复合和危险药物施用期间使用的封闭系统转移装置
4. Transferring innovative (bio)active delivery systems to new products- a challenge for industry and academia [C] . Olaf Bork, Arlene McDowell, Alexandra P. Kafka, Annual meeting exposition of the Controlled Release Society . 2009

机译：将创新的（生物）主动递送系统转移到新产品上-行业和学术界都面临挑战
5. Devices for Biological Systems: On-Chip Horizontal Gene Transfer and 3D-Printed Microfluidic Applications [D] . Brennan, Martin D. 2017

机译：生物系统设备：片内水平基因转移和3D打印微流体应用
6. Closed‐system drug‐transfer devices plus safe handling of hazardous drugs versus safe handling alone for reducing exposure to infusional hazardous drugs in healthcare staff [O] . Kurinchi Selvan Gurusamy, Lawrence MJ Best, Cynthia Tanguay, -1

机译：封闭系统的药物传输设备加上安全处理危险药物与仅安全处理相比减少了医护人员对输注危险药物的接触
7. Overcoming Challenges of Implementing Closed System Transfer Device Clinical In-Use Compatibility Testing for Drug Development of Antibody Drug Conjugates [O] . Frankie Petoskey, Stanley C. Kwok, William Jackson, 2020

机译：克服实施封闭式系统转移装置的挑战临床使用兼容性测试，用于抗体药物缀合物的药物开发
8. Guidance for Industry: New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products [R] . 2009

机译：行业指南：设备和批准的药物和生物制品的新对比成像指示注意事项

Challenges of Using Closed System Transfer Devices With Biological Drug Products: An Industry Perspective

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