Simultaneous global new drug development : multi-regional clinical trials after ICH E17 /: multi-regional clinical trials after ICH E17. (2021)

• Record Type: Book
• Further Information: Note: Edited by Gang Li, Bruce Binkowitz, William Wang, Hui Quan, Josh Chen.
• Editors: Li, Gang; Binkowitz, Bruce; Wang, William; Quan, Hui; Chen, Joshua
• Contents: Chapter 1: General Introduction of E17 ; Yoshiaki Uyama, Yasuto Otsubo, Shuji Kamada, Yoko Aoi; ; Chapter 2: New Principles in Global development using ICH E 17 guideline; Vibeke Bjerregaard, Rominder Singh; Chapter 3: Consideration of "Ethnic Factors" as Defined in ICH E5 for Drug Development and Application in ICH E17 Guidelines for Conduct of Multiregional Clinical Trials (MRCT) ; Rominder Singh, Vibeke Bjerregaard; ; Chapter 4: Pooling Strategy ; Osamu Komiyama, Shintaro Hiro, Nobushige Matsuoka, Hideharu Yamamoto; ; Chapter 5: Overall sample size and allocation to regions; Aloka Chakravarty, Xin Zeng, William Wang ; ; Chapter 6: Consistency Evaluation in MRCTs; William Wang, Armin Koch, Osamu Komiyama ; ; Chapter 7: Implementation of the ICH E17 guideline in Japan; Yoshiaki Uyama, Yasuto Otsubo, Shuji Kamada, Yoko Aoi; ; Chapter 8: ICH E17 and MRCT: Implementation and Regulatory Perspective in China Xin Zeng, Jun Wang, Zhaoyun Wang, Zhimin Yang, Min Li; ; Chapter 9: Lessons Learned from Actual Multi-regional Clinical Trials with Signals of Treatment Effect Heterogeneity; Bruce Binkowitz, Gang Li, Hui Quan, Gordon Lan, Soo Peter Ouyang, Weining Robieson, William Wang, Sammy Yuan, Yoko Tanaka, Josh Chen, Lanju Zhang, Paul Gallo ; Chapter 10: Leveraging Foreign Clinical Data Extrapolation to Accelerate Global Drug Development: A Case Study in Hematological Oncology ; Hongjie Zhu, Jingjing Ye, Xiang Guo; ; Chapter 11: Analysis Models for Multi-regional Clinical Trials; Gang Li, Hui Quan, Gordon KK Lan; ; Chapter 12: Utilization of Robust Estimates of Treatment Effects via Semi-Parametric Models in MRCT; Ming Tan, Shilin Yu, Ao Yuan; ; Chapter 13: Hierarchical Linear Models for Multi-Regional Clinical Trials; Seung-Ho Kang, Saemina Kim; ; Chapter 14: Local Treatment Effect Estimation by Borrowing Information from Similar Regions in Multi-Regional Clinical Trials; Hua Guo, Josh Chen, Hui Quan; ; Chapter 15: Global Drug Development: Multi-Regional Clinical Trials (MRCTs) – China’s Pursuit; Joe Shih, Tai Xie, Kun He; ; Chapter 16: Statistical considerations in MRCT design and analysis; Lanju Zhang, Weining Z Robieson; ; Chapter 17: Multiple Endpoints in Multiregional Clinical Trials; Toshimitsu Hamasaki, Yuh-Jenn Wu, Chinfu Hisio; ; Chapter 18: Multiregional Clinical Trials with Heterogeneous Regional and Treatment Effects; Hsiao-Hui Tsou, Yu-Chieh Cheng, K.K. Gordon Lan, Hsiao-Yu Wu, Ya-Ting Hsu, Fang-Jing Lee, Chi-Tian Chen, Meng-Hsuan Wu, Chin-Fu Hsiao; ; Chapter 19: Regional sample size calculation in multiregional equivalence and non-inferiority trials; Jason Liao, Yaru Shi, Ziji Yu
• Edition: 1st
• Publisher Details: Boca Raton : Chapman & Hall/CRC
• Publication Date: 2021
• Extent: 1 online resource, illustrations (black and white)
• Subjects: 615.19; Drug development
• Languages: English
• ISBNs: 9781000485066; 9781000485028; 9781003109785
• Related ISBNs: 9780367565602
• Notes: Note: Includes bibliographical references and index.; Note: Description based on CIP data; resource not viewed.
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