Overview
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.
Full Product Details
Author: Wei Zhang (Sen. Director & Head of US site, Clin. Dvlpmt & Reg, PPC) ,
Fangrong Yan (China Pharma Univ, China) ,
Feng Chen (Nanjing Med Univ, China) ,
Shein-Chung Chow (Duke Univ, USA)
Publisher: Taylor & Francis Ltd
Imprint: Chapman & Hall/CRC
Weight: 0.703kg
ISBN: 9780367561789
ISBN 10: 0367561786
Pages: 307
Publication Date: 26 May 2022
Audience:
College/higher education
,
General/trade
,
Tertiary & Higher Education
,
General
Format: Hardback
Publisher's Status: Active
Availability: In Print
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.
Reviews
"""This is a must have book for any statistician working in the pharmaceutical industry that wants to have an introductory overview of the most recent and challenging issues and ongoing discussions in the field of statistical regulatory science."" David Manteigas, Cmed Clinical Services, Portugal, ISCB, February 2023"
Author Information
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.
