1st Edition
Advanced Statistics in Regulatory Critical Clinical Initiatives
About the Editors
List of Contributors
Chapter 1 Introduction
Wei Zhang, Fangrong Yan, Feng Chen, and Shein-Chung Chow
Chapter 2 Complex Innovative Design
Beibei Guo and Ying Yuan
Chapter 3 Validation Strategy for Biomarker guided Precision/Personalized Medicine
Hou, Y., Li, M.J., and Li, K.
Chapter 4 Model-Informed Drug Development
Haochen Liu, Fangrong Yan
Chapter 5 Real-world data and real-world evidence
Xin Sun
Chapter 6 AI/ML in Medical Research and Drug Development
Amir Nikooienejad and Haoda Fu
Chapter 7 Challenges in Cancer Clinical Trials
Xia, Fan; Lin, Xiao; Guo, Xiang
Chapter 8 Statistical Methods for Assessment of Biosimilars
Yafei Zhang, Vivian Gu, Xiuyu Julie Cong, and Shein-Chung Chow
Chapter 9 Statistical Methods for Assessment of Complex Generic Drugs
Peiyong Yu, Xiaoyan Yan and Chen Yao
Chapter 10 Rare Diseases Drug Development
Shein-Chung Chow, Shutian Zhang, Wei Zhang
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.
"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
