FDA guidance on prophylactic DNA vaccines: analysis and recommendations.
FDA guidance on prophylactic DNA vaccines: analysis and recommendations.
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DOI:
10.1016/j.vaccine.2009.11.025
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发表时间:
2010-04-01
期刊:
影响因子:
5.5
通讯作者:
Steinhagen, Folkert
中科院分区:
文献类型:
--
作者:
Klinman, Dennis M.;Klaschik, Sven;Tross, Debra;Shirota, Hidekazu;Steinhagen, Folkert
The FDA has been regulating the conduct of prophylactic DNA vaccine trials in the US for nearly 15 years. This work describes the evolution of FDA policy over that period, the status of current regulatory guidance, and provides recommendations for further changes to facilitate development in this field.
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DOI:
10.1084/jem.186.9.1481
发表时间:
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期刊:
The Journal of experimental medicine
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作者:
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