Pharmaceutical Regulatory Affairs: Open Access

Fuyu Song

Publications

• Review Article
  On Statistical Principles for Clinical Trials in Pharmaceutical Development – A Review of China FDA Draft Guidance
  Author(s): Shein-Chung Chow, Zinan Chen and Fuyu SongShein-Chung Chow, Zinan Chen and Fuyu Song
  
  On August 21, 2015, the Center for Drug Evaluation (CDE) of China Food and Drug Administration (CFDA) circulated draft guidance on Statistical Principles for Clinical Trials in Pharmaceutical Development for public comments. The draft guidance is to assist the sponsor for providing accurate and reliable assessment of a test treatment under investigation in China. The draft guidance focuses on study designs, basic considerations for on-going trials, data management, and statistical principles for data analysis and reporting. In this article, we intend to comment on the draft guidance and provide constructive input and recommenda.. Read More»
  DOI: 10.4172/2167-7689.1000152

  Abstract PDF