双能X射线骨密度仪技术审评关键问题探讨

      Discuss about Key Issues of Dual Energy X-ray Absorptiometry Evaluation

      • 摘要: 双能X射线骨密度仪是目前临床最常用的骨密度测量方法,其测量涉及核心临床功能,并与体模、参考数据库息息相关。该文对双能X射线骨密度仪的核心临床功能、体模和参考数据库三个关键问题的技术审评要求进行探讨,以期帮助制造商在研发生产过程中科学开展相关过程,提高其注册申报资料的质量。

         

        Abstract: The Dual energy X-ray absorptiometry is the most commonly used for measuring bone mineral density. This method involves core clinical functions, phantom and database. This article discusses the three key issues of dual energy X-ray absorptiometry evaluation, including core clinical functions, phantom and database. This article aims at helping manufacturers to scientifically carry out relevant processes during research and development and also manufacturers may refer to this article when they apply for registration.

         

      /

      返回文章
      返回