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The Judicial Regulation for Security of Nano-drug

Author: LiuBin
Tutor: LuoYuZhong
School: Huazhong University of Science and Technology
Course: Legal
Keywords: Nanotechnology Nanomedicine Security Clinical trials Control
CLC: D922.16
Type: Master's thesis
Year: 2011
Downloads: 44
Quote: 0
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Abstract


Nanotechnology emerged in the eighties and nineties of the last century , and by 2000 was raised about nanotechnology important role in the pharmaceutical field . However , nanotechnology potential applications in the pharmaceutical field is very impressive, it is in the development of new drugs, drug delivery systems , medical equipment , and played an important role endless . Since then, various national governments in order to seize the application of nanotechnology in the commanding heights of the pharmaceutical field , have spent a lot to advance its research and development, and announced and start some columns \Nanotechnology as an emerging technology , it is not only in the pharmaceutical field of application to bring considerable benefits to human health , but also because its technology is different from other disciplines , which is a highly cross \Therefore, we have to take into account this new technology brought to mankind will have a positive effect at the same kind of security risk. We have been hoping this emerging nanotechnology techniques combined with traditional pharmaceutical field for human health and safety and make great contributions . The author certainly nanomedicine bring hope to mankind , while also taking into account the development of nano- drugs in the process of how their research potential security issues for prevention and regulation, how to conduct research and development of nano- drugs toxicological safety assessment . For traditional medicines in clinical trials has been tested for the protection of persons affected by the case of poor how to determine the clinical research stage nano- safety regulation, especially for the \nano drug clinical trial legislative ideas. Nano drugs with generic drugs in the physicochemical properties of the difference makes it licensure will be more strict, and received much scrutiny. Finally, this paper for nano drug safety laws hoping to play a regulatory effect of forward , allowing the focus of everyone's attention from the benefits of nanomedicine shifted to how the legislation on their potential risk prevention regulation, to better use emerging technologies for human health services .

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