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The Judicial Regulation For Security Of Nano-drug

Posted on:2012-01-05Degree:MasterType:Thesis
Country:ChinaCandidate:B LiuFull Text:PDF
GTID:2216330362457602Subject:Law
Abstract/Summary:PDF Full Text Request
Nanotechnology rises in the 1980s and 1990s, but the application of nanotechnology in medicine research and clinical areas plays an important role around the year 2000. However, the application of nanotechnology in pharmaceutical field has considerable potential. It plays an important part in new drug research, drug delivery system and medical devices. Since then, many countries preempt the commanding heights of nanotechnology in pharmaceutical field application. They invest capitals to this. Nanotechnology as a new technology, the application of it in pharmaceutical field to human health dose not only bring considerable benefits, but also has disadvantage due to its different from other disciplines. It is a science technology called"bottom"technology; we have to consider its safety risk.We always hope that nanotechnology will make a great contribution to human body health combine traditional pharmaceutical. The author believe that nano-drugs bring hopes at the same time, and still considering the nano-drugs in research and development process of it is possible to bring some security problems, and how to prevent and regulate these. Under the condition of the lack of protection in traditional medicine clinical trials on testers, how to determine the safety supervision in nano-drug clinical study phase is we need to consider. Especially for the imperfection in GMP, the author puts forward how to improve it. Nano-drug has different physical and chemical properties with common medicines so that it will be examined and approved by strict control.Finally, through the discussion to the judicial regulation for security of nano-drug, the author hope it could generate a thoughtful effect, meanwhile it could absorb everybody's attention and let this attention transfer from the benefits of nanometer drugs to how to legislate to evade its potential risks, in this way, human could use new technology for human health services preferably.
Keywords/Search Tags:nanotechnology, nano-drug, safety, clinical trials, regulation
PDF Full Text Request
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