肠外用药封闭系统药物转移装置的现行行业规范。

IF 3.7 3区医学 Q2 CHEMISTRY, MEDICINAL

Journal of pharmaceutical sciences Pub Date : 2025-03-01 DOI:10.1016/j.xphs.2025.01.019

Isabella de Jong , David Cheng Thiam Tan , Christian Lehermayr , Mollie Daugherty , Vasco Filipe , Matthias Winzer , Stanley C. Kwok , Annette Medina , Allison Guy , Twinkle Christian , Shubhadra N. Singh , Soumendu Bhattacharya , Serene Jabary

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引用次数: 0

摘要

USP和NIOSH提供了在医疗保健环境中使用封闭系统药物转移装置用于危险药物的指南。然而，无论药物危害状况如何，临床场所都使用性病。在本文中，介绍了以前的出版物描述评估和CSTD风险评估策略。此外，还进行了一项制药业调查，以描述目前评估cstd的策略以及如何管理这些设备用于临床研究。最后，提出了减轻与性病相关风险的建议。这些建议包括：测试考虑、风险评估和沟通。

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Current industry practices on closed system drug-transfer devices for parenteral drug products

USP<800> and NIOSH provide guidance on the use of Closed System Drug-Transfer Devices for hazardous drug in the healthcare setting. However, CSTDs are used by clinical sites irrespective of drug hazard status. In this paper, previous publications that describe evaluation and CSTD risk assessment strategies are presented. In addition, a pharmaceutical industry survey was performed to describe the current strategies for evaluation of CSTDs and how these devices are managed for clinical studies. Finally, recommendations are proposed to mitigate risks associated with CSTDs. These recommendations incorporate: testing considerations, risk assessments, and communication.

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来源期刊

Journal of pharmaceutical sciences 医学-化学综合

CiteScore

7.30

自引率

13.20%

发文量

367

审稿时长

33 days

期刊介绍： The Journal of Pharmaceutical Sciences will publish original research papers, original research notes, invited topical reviews (including Minireviews), and editorial commentary and news. The area of focus shall be concepts in basic pharmaceutical science and such topics as chemical processing of pharmaceuticals, including crystallization, lyophilization, chemical stability of drugs, pharmacokinetics, biopharmaceutics, pharmacodynamics, pro-drug developments, metabolic disposition of bioactive agents, dosage form design, protein-peptide chemistry and biotechnology specifically as these relate to pharmaceutical technology, and targeted drug delivery.