LEADER 00000cam  2200673Mi 4500 
001    796383463 
003    OCoLC 
005    20200921045835.8 
006    m     o  d         
007    cr cnu---unuuu 
008    120625s2013    flu     ob    001 0 eng d 
020    9781439846353 
020    1439846359 
020    9781439846346 
020    1439846340 
035    Ebook Central DDA Titles 
035    (OCoLC)796383463|z(OCoLC)811205615|z(OCoLC)987450727
       |z(OCoLC)1031042546|z(OCoLC)1086431038 
035    Taylor & Francis All eBooks 
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049    txum 
050  4 RM301.27|b.D47 2013 
072  7 MED|x023000|2bisacsh 
072  7 MED|x058170|2bisacsh 
072  7 MED|x071000|2bisacsh 
072  7 MED|x072000|2bisacsh 
082 04 615.10727 
245 00 Design and analysis of bridging studies /|cedited by Jen-
       pei Liu, Shein-Chung Chow, Chin-Fu Hsiao. 
260    Boca Raton, FL :|bCRC Press,|c2013. 
300    1 online resource (xviii, 269 pages) 
336    text|btxt|2rdacontent 
337    computer|bc|2rdamedia 
338    online resource|bcr|2rdacarrier 
490 1  Chapman & Hall/CRC Biostatistics Series 
504    Includes bibliographical references and index. 
505 0  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. 
506    Available only to authorized UTEP users. 
520    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. 
588 0  Print version record. 
650  0 Drugs|xTesting|xStatistical methods. 
650  0 Pharmacy|xResearch|xStatistical methods. 
650  0 Drug development|xStatistical methods. 
700 1  Hsiao, Chin-Fu,|d1964- 
700 1  Liu, Jen-pei,|d1952- 
700 1  Chow, Shein-Chung,|d1955- 
776 08 |iPrint version:|aHsiao, Chin-Fu.|tDesign and Analysis of 
       Bridging Studies.|dHoboken : CRC Press, ©2012
       |z9781439846346 
830  0 Chapman & Hall/CRC biostatistics series. 
856 40 |uhttp://0-www.taylorfrancis.com.lib.utep.edu/books/
       9780429105159|zTo access this resource 
856 40 |uhttp://0-ebookcentral.proquest.com.lib.utep.edu/lib/utep
       /detail.action?docID=945467|zTo access this resource 
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