Advanced statistics in regulatory critical clinical initiatives. (2022)

• Record Type: Book
• Further Information: Note: Edited by Wei Zhang, Fangrong Yan, Feng Chen and Shein-Chung Chow.
• Editors: (Biometrician), Zhang, Wei; Yan, Fangrong; (Professor of biostatistics), Chen, Feng; Chow, Shein-Chung, 1955-
• Contents: 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
• Edition: 1st
• Publisher Details: Boca Raton : Chapman & Hall/CRC
• Publication Date: 2022
• Extent: 1 online resource, illustrations (black and white)
• Subjects: 615.10724; Drugs -- Testing -- Statistical methods; Clinical trials -- Statistical methods; Biometry; Drugs -- Standards -- United States; Clinical trials -- Law and legislation -- United States
• Languages: English
• ISBNs: 9781000568028; 9781000567991; 9781003107323
• Related ISBNs: 9780367561789
• Notes: Note: Includes bibliographical references and index.; Note: Description based on CIP data; resource not viewed.
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• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.