开发供人类使用的纳米药物的机遇与障碍。

IF 2.5 4区 医学 Q3 PHARMACOLOGY & PHARMACY DARU Journal of Pharmaceutical Sciences Pub Date : 2016-10-06 DOI:10.1186/s40199-016-0163-8
Nasser Nassiri Koopaei, Mohammad Abdollahi
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引用次数: 0

摘要

制药纳米技术自出现以来,在改善医疗保健和人类生活方面取得了突破性发展。所采用的生物材料主要用于改进给药系统、成像和诊断技术,而纳米级材料则广泛应用于电子和光学等其他行业。这种进步可能会给药物开发和治疗带来革命性的变化,带来更有效的新疗法。尽管纳米技术有助于改善人类的福祉,但它也有一定的局限性,需要监管和科学机构进行彻底调查。为了解决人们对纳米药物安全性和毒性的担忧,我们回顾了纳米药物在人类健康中的应用所面临的挑战和解决方案,以及相关的健康风险。在这方面,各国的食品和药物管理局(FDA)、经济合作与发展组织(OECD)、欧洲药品管理局(EMA)、环境保护局(EPA)、国家职业安全与健康研究所(NIOSH)和世界卫生组织(WHO)等监管和科学机构可参与制定和加强安全措施和监管框架,以确保公众健康。监管当局可强制纳米制药行业进行全面的毒性测试,并与科学界密切合作监测药物不良反应报告,以便采取相应行动,并在战略实施过程中告知公众。纳米药物作为治疗或诊断药物在人类使用方面具有巨大潜力。但当局应妥善处理其毒性问题,并制定和加强相应的监管框架。
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Opportunities and obstacles to the development of nanopharmaceuticals for human use.

Pharmaceutical nanotechnology has generated breakthrough developments in improving health care and human life from its emergence. The biomaterials employed mainly aim at improving drug delivery systems, imaging and diagnostic technologies while the nanoscale materials are in widespread use in other industries such as electronics and optics. Such advancement may revolutionize the drug development and therapy with new and more efficient treatments. Although, nanotechnology assists humankind in improving its well being, it has certain limitations that entail thorough investigation by the regulatory and scientific authorities. To address concerns regarding the safety and toxicity profile of the nanopharmaceuticals, we have reviewed the challenges and solutions of nanopharmaceuticals use in human health and the related health risks. In this regard, regulatory and scientific bodies such as countries' Food and Drug Administration (FDA), Organization for Economic Co-operation and Development (OECD), European Medicine Agency (EMA), Environmental Protection Agency (EPA), National Institute for Occupational Safety and Health (NIOSH), and World Health Organization (WHO) can participate in developing and reinforcing safety measures and regulatory frameworks to insure the public health. The regulatory authorities may enforce the nanopharmaceutical industries to conduct comprehensive toxicity tests and monitor the adverse drug reaction reports in close collaboration with the scientific community to act accordingly and inform the public as the implementation of the strategy. Nanopharmaceuticals have tremendous potential for human use as therapeutic or diagnostic agents. But their toxicity profile should be well addressed and the respective regulatory framework developed and reinforced by the authorities.

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来源期刊
DARU Journal of Pharmaceutical Sciences
DARU Journal of Pharmaceutical Sciences PHARMACOLOGY & PHARMACY-
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期刊介绍: DARU Journal of Pharmaceutical Sciences is a peer-reviewed journal published on behalf of Tehran University of Medical Sciences. The journal encompasses all fields of the pharmaceutical sciences and presents timely research on all areas of drug conception, design, manufacture, classification and assessment. The term DARU is derived from the Persian name meaning drug or medicine. This journal is a unique platform to improve the knowledge of researchers and scientists by publishing novel articles including basic and clinical investigations from members of the global scientific community in the forms of original articles, systematic or narrative reviews, meta-analyses, letters, and short communications.
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