Multiregional clinical trials for simultaneous global new drug development. (2016)

• Record Type: Book
• Further Information: Note: Edited by Joshua Chen and Hui Quan.
• Editors: Chen, Joshua; Quan, Hui, 1972-
• Contents: Simultaneous Global Development; The Journey to Multiregional Clinical Trials in Support of Simultaneous Global Product Development; Christy Chuang-Stein General Principles and Considerations in Multiregional Clinical Trials for Simultaneous Global New Drug Development; Ekopimo Ibia and Bruce Binkowitz Bridging Studies versus Multiregional Trials; Weichung J. Shih Multiregional Clinical Trial : Design Considerations; Multiregional Clinical Trials: Assessing Consistency of Treatment Effect; Joshua Chen and Hongwei Wang Regulatory Perspectives: Different Requirements/Endpoints and Needs for Harmonization; Cynthia J. Girman and Bruce Binkowitz Intrinsic and Extrinsic Factors and Rationales to Be Considered When Defining Regions; Yoko Tanaka Models and Sample Sizes for Multiregional Clinical Trials Hui Quan and Mingyu Li Multiregional Clinical Trials in Oncology Drug Development; Mingxiu Hu A Few More Considerations in Multiregional Clinical Trials on Regional Differences; Bo Yang and Yijie Zhou Optimal Multiregional Clinical Trials; Zhaoyang Teng and Mark Chang Implementation of Multiregional Clinical Trial Design; Xuezhou Mao and Mingyu Li Multiregional Clinical Trial : Data Monitoring Committee and Monitoring Regional Difference; Independent Data Monitoring Committees in Multiregional Clinical Trials; Janet Wittes Monitoring Regional Difference Based on Blinded Data in Multiregional Clinical Trials; Joshua Chen Adaptive Multiregional Clinical Trials; Zhaoyang Teng and Mark Chang Multiregional Clinical Trial : Analysis, Reporting, and Interpretation; Lessons Learned and Recommendations Regarding Multiregional Clinical Trials from a Well-Practiced Industry Statistician; Bruce Binkowitz Quantification of Regional Treatment Effects for Multiregional Clinical Trials; Hui Quan and Xuezhou Mao Multiregional Clinical Trials: Country-Specific Assessment; Joshua Chen and Xuezhou Mao Multiregional Outcome Trial for a Multivalent Human Papillomavirus Vaccine: A Case Study; Oliver M. Bautista, Erin Moeller, and Alain Luxembourg Multiregional Clinical Trial : Latest Development and Trend; The Discrete Random-Effects Model: Assessing Benefit and Consistency of Treatment Effect; Hsiao-Hui Tsou, K.K. Gordon Lan, Jung-Tzu Liu, and Chin-Fu Hsiao New Drug Development Paradigms in China: Simultaneous Global Drug Development Program; Gang Chen, Qin Huang, Frank Shen, Zhilong Yuan, and Dayao Zhao Special Considerations for Emerging Markets; Gang Li and Jun Zhao A Predictive Bayesian Approach to the Design and Analysis of Bridging Studies; A. Lawrence Gould and William W.B. Wang Multiregional Clinical Trial: Japanese Viewpoint; Madoka Takeuchi and Masahiro Takeuchi Special Considerations for Medical Devices: An Overview; Yunling Xu, Nelson Lu, and Gerry Gray Use of Multinational Randomized Clinical Trials in Economic Evaluations of Health Care; Joseph Heyse, Jieling Chen, and John Cook Regional Benefit and Risk Evaluations; Soo Peter Ouyang and Hui Quan Index
• Edition: 1st
• Publisher Details: Boca Raton : Chapman & Hall/CRC
• Publication Date: 2016
• Extent: 1 online resource, illustrations (black and white)
• Subjects: 615.19; Drug development; Clinical trials; Drugs -- Testing
• Languages: English
• ISBNs: 9781498701488
• Related ISBNs: 9781498701464
• Notes: Note: Includes bibliographical references and index.; Note: Description based on CIP data; item not viewed.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• 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.