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Advanced Statistics in Regulatory Critical Clinical Initiatives on Hardback
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Advanced Statistics in Regulatory Critical Clinical Initiatives

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Description

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. Advanced Statistics in Regulatory Critical Clinical Initiatives provides innovative ways to resolve common challenges in statistical research of rare diseases such small sample sizes and provides guidance for combined use of data. With analysis from regulatory and scientific perspectives this book is an ideal companion for researchers in biostatistics, pharmaceutical development, and policy makers in related fields. Key Features: Provides better understanding of innovative design and analysis of each critical clinical initiatives which may be used in regulatory review/approval of drug development. Makes recommendations to evaluate submissions accurately and reliably. Proposes innovative study designs and statistical methods for oncology and/or rare disease drug development. Provides insight regarding current regulatory guidance on drug development such as gene therapy and rare diseases.

Author Biography:

Wei Zhang is the Vice President, Head of Biometrics at AffaMed Therapeutics, New York. Fangrong Yan is a Professor of Biostatistics in the School of Science, and Director of Biostatistics and Computational Pharmacy Research Center at China Pharmaceutical University (CPU). Feng Chen is a Professor of Biostatistics in School of Public Health, Nanjing Medical University (NJMU). Shein-Chung Chow is currently a Professor at the Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham.
Release date Australia
May 26th, 2022
Audiences
  • General (US: Trade)
  • Tertiary Education (US: College)
Contributors
  • Edited by Fangrong Yan
  • Edited by Feng Chen
  • Edited by Shein-Chung Chow
  • Edited by Wei Zhang
Illustrations
21 Tables, black and white; 30 Line drawings, black and white; 30 Illustrations, black and white
Pages
307
ISBN-13
9780367561789
Product ID
35348702

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