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Title Design and analysis of bridging studies / edited by Jen-pei Liu, Shein-Chung Chow, Chin-Fu Hsiao.
Imprint Boca Raton, FL : CRC Press, 2013.


 Internet  Electronic Book    AVAILABLE
Description 1 online resource (xviii, 269 pages)
Series Chapman & Hall/CRC Biostatistics Series
Chapman & Hall/CRC biostatistics series.
Bibliog. Includes bibliographical references and index.
Note Available only to authorized UTEP users.
Print version record.
Subject Drugs -- Testing -- Statistical methods.
Pharmacy -- Research -- Statistical methods.
Drug development -- Statistical methods.
Contents 1. Bridging diversity : extrapolating foreign data to a new region / Shein-Chung Chow and Chin-Fu Hsiao -- 2. Two-stage designs of bridging studies / Chin-Fu Hsiao [and others] -- 3. Consistency of treatment effects in bridging studies and global multiregional trials / Weichung J. Shih and Hui Quan -- 4. Assessing similarity using the reproducibility and generalizability probabilities and the sensitivity index / Shein-Chung Chow, Ying Lu, and Lan-Yan Yang -- 5. Combining information in clinical drug development : bridging studies and beyond / Kuang-Kuo Gordon Lan and Jose Pinheiro -- 6. A Bayesian approach for evaluation of bridging studies / Chin-Fu Hsiao [and others] -- 7. Issues of sample size in bridging trials and global clinical trials / Hsien-Ming James Hung, Sue-Jane Wang, and Robert O'Neill -- 8. Design and sample size considerations for global trials / Christy Chuang-Stein [and others] -- 9. Application of genomic technologies for bridging strategy involving different race and ethnicity in pharmacogenomics clinical trials / Sue-Jane Wang -- 10. Interaction effects in bridging studies / Eric Tsung-Cheng Hsieh and Jen-pei Liu -- 11. Multiregional clinical trials / Yi Tsong and Hsiao-Hui Tsou -- 12. Multiregional clinical trials for global simultaneous drug development in Japan / Kihito Takahashi, Mari Ikuta, and Hiromu Nakajima -- 13. Feasibility and implementation of bridging studies in Taiwan / Mey Wang, Yeong-Liang Lin, and Herng-Der Chern.
Summary This book provides a comprehensive and unified summary of the growing literature and research activities on regulatory requirements, scientific and practical issues, and statistical methodology pertaining to the design and evaluation of bridging studies, which provide pharmacodynamic or clinical data that allow extrapolation of the foreign clinical data to a new region. Along with a thorough overview of bridging studies, the text addresses issues arising from bridging studies, including ethnic sensitivity, necessity of bridging studies, types of bridging studies, and assessment of similarity b.
Other Author Hsiao, Chin-Fu, 1964-
Liu, Jen-pei, 1952-
Chow, Shein-Chung, 1955-
Other Title Print version: Hsiao, Chin-Fu. Design and Analysis of Bridging Studies. Hoboken : CRC Press, ©2012 9781439846346