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Title Statistics in the pharmaceutical industry / edited by C. Ralph Buncher, Jia-Yeong Tsay.
Imprint Boca Raton, FL : Chapman & Hall/CRC, 2006.


 Internet  Electronic Book    AVAILABLE
Edition 3rd ed.
Description 1 online resource (xxiii, 473 pages) : illustrations.
Series Biostatistics (New York, N.Y.) ; 14
Biostatistics (New York, N.Y.) ; 14.
Bibliog. Includes bibliographical references and index.
Note Available only to authorized UTEP users.
Subject Pharmacy -- Statistical methods.
Pharmaceutical industry -- Statistical methods.
Drugs -- Testing.
Contents Ch. 1. Introduction to the evolution of pharmaceutical products / C. Ralph Buncher and Jia-Yeong Tsay -- ch. 2. Statistical review and evaluation of animal carcinogenicity studies of pharmaceuticals / Karl K. Lin and Mirza W. Ali -- ch. 3. The FDA and the IND/NDA statistical review process / Satya D. Dubey, George Y.H. Chi, and Roswitha E. Kelly -- ch. 4. Clinical trial designs / C. Ralph Buncher and Jia-Yeong Tsay -- ch. 5. Selecting patients for a clinical trial / C. Ralph Buncher and Jia-Yeong Tsay -- ch. 6. Statistical aspects of cancer clinical trials / T. Timothy Chen -- ch. 7. Recent statistical issues and developments in cancer clinical trials / Weichung Joe Shih -- ch. 8. Design and analysis of testosterone replacement therapy trials / Ted M. Smith -- ch. 9. Clinical trials of analgesic drugs / Cynthia G. McCormick -- ch. 10. Statistical issues in HIV/AIDS research / Ronald J. Bosch and C. Ralph Buncher -- ch. 11. The wonders of placebo / C. Ralph Buncher -- ch. 12. Active-controlled noninferiority/equivalence trials : methods and practice / Irving K. Hwang -- ch. 13. Interim analysis and bias in clinical trials : the adaptive design perspective / Qing Liu and Gordon Pledger -- ch. 14. Interim analysis and adaptive design in clinical tirials / Irving K. Hwang and K.K. Gordon Lan -- ch. 15. A regulatory perspective on data monitoring and interim analysis / Robert T. O'Neill -- ch. 16. Complex adaptive systems, human health, and drug response : statistical challenges in pharmacogenomics / Kim E. Zerba and C. Frank Shen -- ch. 17. Phase IV postmarketing studies / C. Ralph Buncher and Jia-Yeong Tsay -- ch. 18. The role of contract research organizations in clinical research in the pharmaceutical industry / Roger E. Flora and John Constant -- ch. 19. Global harmonization of drug development : a clinical statistics perspective / Peter H. van Ewijk, Bernhard Huitfeldt, and Jia-Yeong Tsay -- ch. 20. Bridging strategies in global drug development / Mamoru Narukawa and Masahiro Takeuchi -- ch. 21. Design and analysis strategies for clinical pharmacokinetic trials / Lianng Yuh and Yusong Chen -- ch. 22. Stability studies of pharmaceuticals / Yi Tsong [and others] -- ch. 23. When and how to do multiple comparisons / Charles W. Dunnett and Charles H. Goldsmith -- ch. 24. Refence intervals (ranges) : distribution-free methods vs. normal theory / Paul S. Horn and Amadeo J. Pesce.
Other Author Buncher, C. Ralph (Charles Ralph), 1938-
Tsay, Jia-Yeong, 1944-
Other Title 9780824754693 0824754697