Current Trends and Challenges in the Clinical Translation of Nanoparticulate Nanomedicines: Pathways for Translational Development and Commercialization.
Current Trends and Challenges in the Clinical Translation of Nanoparticulate Nanomedicines: Pathways for Translational Development and Commercialization.
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DOI：
10.3389/fphar.2018.00790
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发表时间：
2018
影响因子：
5.6
通讯作者：
Storm G
中科院分区：
文献类型：
--
作者：
Hua S;de Matos MBC;Metselaar JM;Storm G
纳米技术在医学中的应用有可能对人类健康产生重大影响，以预防、诊断和治疗疾病。纳米医学领域备受关注的一个特殊方面是用于药物输送的纳米颗粒纳米药物（NNM）（即含药纳米颗粒）的设计和开发。 NNM 旨在通过各种机制递送药物：增溶、被动靶向、主动靶向和触发释放。 NNM 方法旨在提高治疗效果、降低治疗有效剂量和/或降低全身副作用的风险。为了将 NNM 从实验室转移到临床，需要解决几个实验挑战。本综述将讨论 NNM 临床转化的当前趋势和挑战，以及转化开发和商业化的潜在途径。将涵盖与 NNM 临床开发相关的关键问题，包括生物学挑战、大规模制造、生物相容性和安全性、知识产权 (IP)、政府法规以及与当前疗法相比的总体成本效益。这些因素可能会造成重大障碍，限制 NNM 在市场上的出现，无论它们是否具有治疗益处。
The use of nanotechnology in medicine has the potential to have a major impact on human health for the prevention, diagnosis, and treatment of diseases. One particular aspect of the nanomedicine field which has received a great deal of attention is the design and development of nanoparticulate nanomedicines (NNMs) for drug delivery (i.e., drug-containing nanoparticles). NNMs are intended to deliver drugs via various mechanisms: solubilization, passive targeting, active targeting, and triggered release. The NNM approach aims to increase therapeutic efficacy, decrease the therapeutically effective dose, and/or reduce the risk of systemic side effects. In order to move a NNM from the bench to the bedside, several experimental challenges need to be addressed. This review will discuss the current trends and challenges in the clinical translation of NNMs as well as the potential pathways for translational development and commercialization. Key issues related to the clinical development of NNMs will be covered, including biological challenges, large-scale manufacturing, biocompatibility and safety, intellectual property (IP), government regulations, and overall cost-effectiveness in comparison to current therapies. These factors can impose significant hurdles limiting the appearance of NNMs on the market, irrelevant of whether they are therapeutically beneficial or not.
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影响因子：
5.5
作者：
Bawa, Raj
通讯作者：
Bawa, Raj
影响因子：
5.6
作者：
Accomasso L;Cristallini C;Giachino C
通讯作者：
Giachino C
DOI：
10.1016/j.nano.2005.03.009
发表时间：
2005-06-01
影响因子：
5.4
作者：
Bawa, Raj;Bawa, S. R.;Wei, Chiming
通讯作者：
Wei, Chiming
影响因子：
10.8
作者：
Coimbra, Maria;Banciu, Manuela;Schiffelers, Raymond M.
通讯作者：
Schiffelers, Raymond M.
影响因子：
3.5
作者：
GREGORIA.G;LEATHWOO.PD;RYMAN, BE
通讯作者：
RYMAN, BE