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同情用药制度对我国罕见病患者用药可及性研究
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作者 黄晓翠 梁毅 《中国药事》 CAS 2023年第5期527-534,共8页
目的:基于国内罕见病患者用药可及性现状,剖析国外同情用药的制度体系及实施成效,深入分析同情用药制度对国内罕见病患者的用药可及性问题,并提出贴合国内罕见病患者同情用药制度落实的细则。方法:查阅美国FDA发布的法规政策、技术指南... 目的:基于国内罕见病患者用药可及性现状,剖析国外同情用药的制度体系及实施成效,深入分析同情用药制度对国内罕见病患者的用药可及性问题,并提出贴合国内罕见病患者同情用药制度落实的细则。方法:查阅美国FDA发布的法规政策、技术指南、相关统计数据及文献资料,对美国同情用药的使用类别、申请及审批流程、费用支付方式等内容进行分析。结果与结论:美国已具备较为完善的同情用药制度体系,该制度在我国的建立或将成为国内罕见病患者用药可及的一条新路径,在一定程度上能够提高国内罕见病患者的用药可及性。 展开更多
关键词 罕见病 研究型新药物 同情用药 临床试验药物拓展使用 用药可及性
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Advances in the formulation and defivery technology of paclitaxel for injection 被引量:2
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作者 Jing Sun Wenbing Dai Zhe Liang Zhaoyang wang Changsheng Huang Bing He Hua Zhang Xueqing Wang Qiang Zhang 《Journal of Chinese Pharmaceutical Sciences》 CAS CSCD 2015年第8期487-500,共14页
Paclitaxel is a promising antineoplastic agent against a variety of human solid tumors, such as ovary, breast, lung, head and neck tumors, and melanoma. Owing to its poor solubility, the fast available formulation ofp... Paclitaxel is a promising antineoplastic agent against a variety of human solid tumors, such as ovary, breast, lung, head and neck tumors, and melanoma. Owing to its poor solubility, the fast available formulation ofpaclitaxel (Taxol) exists as a non-aqueous concentrate composed of Cremophor EL (polyethoxylated castor oil) and ethanol. It must be diluted to a suitable aqueous solution prior to long time intravenous infusion. Based on the components and usage, Taxol has serious adverse effects and is inconvenient for clinical use. To address these problems, the development of a less-toxic, better-tolerated, Cremophor EL-free formulation of paclitaxel has been attempted. In recent years, new drug delivery systems (DDS) including albumin-based nanoparticles, micelles, liposomes, etc. have been investigated. In this review, we present the formulations and delivery technologies of paclitaxel for injection and focus on some of preclinical and clinical experience on the formulations which are already on the market or under clinical stages. Finally, possible nanotechnology advantages, existing challenges and future perspectives of paclitaxel delivery are highlighted. 展开更多
关键词 PACLITAXEL TAXOL Preclinical and clinical studies New drug delivery system
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