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FDA Guidance on Prophylactic DNA Vaccines: Analysis and Recommendations

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 fi...

詳細記述

保存先:
書誌詳細
主要な著者: Klinman, Dennis M., Klaschik, Sven, Tross, Debra, Shirota, Hidekazu, Steinhagen, Folkert
フォーマット: Artigo
言語:Inglês
出版事項: 2009
主題:
オンライン・アクセス:https://ncbi.nlm.nih.gov/pmc/articles/PMC2847045/
https://ncbi.nlm.nih.gov/pubmed/19941989
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.vaccine.2009.11.025
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