Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development. It provides innovative ways to resolve common challenges in statistical research of rare diseases such small sample sizes and gives help for combined use of data. 317 p.

Series: Chapman & Hall/CRC Biostatistics Series

PREVIEW
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• Wei Zhang, Editor. PhD; Vice President, Head of Biometrics at AffaMed Therapeutics, New York, NY (USA); and works at the United States Food and Drug Administration (FDA) as a master statistical reviewer and supervisory mathematical statician.
• Fangrong Yan, Editor. PhD; Professor of Biostatistics at the School of Science; and Director of Biostatistics and Computational Pharmacy Research Center at the China Pharmaceutical University (CPU); he is a visiting scholar in the Department of Biostatistics, MD Anderson Cancer Research Center, Houston, TX (USA).
• Feng Chen, Editor. BSc in Mathematics, PhD in Biostatistics; Professor of Biostatistics in the School of Public Health, Nanjing Medical University (NJMU); and currently the Chairperson of the China Association of Biostatistics (CABS); and Chairperson of the China Clinical Trial Statistics (CCTS) working group. Et al...
  
   
• Publication dates (electronic format): 2022-05 - A Chapman & Hall Book.