Advanced Statistics in Regulatory Critical Clinical Initiatives

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.

• 1 Introduction, 2 Complex Innovative Design, 3 Validation Strategy for Biomarker guided Precision/Personalized Medicine, 4 Model-Informed Drug Development, 5 Real-world data and real-world evidence, 6 AI/ML in Medical Research and Drug Development, 7 Challenges in Cancer Clinical Trials, 8 Statistical Methods for Assessment of Biosimilars, 9 Statistical Methods for Assessment of Complex Generic Drugs, 10 Rare Diseases Drug Development

"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