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STATISTICS IN THE PHARMACEUTICAL INDUSTRY, 3RD EDITION By C. Ralph Buncher NEW - Picture 1 of 1

Chapman and Hall/CRC Biostatistics Ser.: Statistics in the Pharmaceutical Industry by Jia-Yeong Tsay (2005, Hardcover, Revised edition,Expanded,New Edition)

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STATISTICS IN THE PHARMACEUTICAL INDUSTRY, 3RD EDITION (CHAPMAN & HALL/CRC BIOSTATISTICS SERIES) By C. Ralph Buncher, Jia-yeong Tsay - Hardcover **BRAND NEW**.

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The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, Statistics in the Pharmaceutical Industry has been the definitive guide to sorting through the challenges in the industry, and this Third Edition continues that tradition. Updated and expanded to reflect the most recent trends and developments in the field, Statistics in the Pharmaceutical Industry, Third Edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies who discuss everything from experimental design to post-marketing studies. This approach sheds light on what regulators consider acceptable methodologies and what methods have proven successful for industrial statisticians. Both new and revised chapters reflect the increasingly global nature of the industry as represented by authors from Japan and Europe, the increasing trend toward non-inferiority/equivalence testing, adaptive design in clinical trials, global harmonization of regulatory standards, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies. Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for anyone performing statistical analysis at any point in the drug approval process.

Product Identifiers

Publisher
CRC Press LLC
ISBN-10
0824754697
ISBN-13
9780824754693
eBay Product ID (ePID)
45406071

Product Key Features

Author
Jia-Yeong Tsay
Publication Name
Statistics in the Pharmaceutical Industry
Format
Hardcover
Language
English
Publication Year
2005
Series
Chapman and Hall/Crc Biostatistics Ser.
Type
Textbook
Number of Pages
504 Pages

Dimensions

Item Length
9.4in
Item Height
1.2in
Item Width
6.9in
Item Weight
27.3 Oz

Additional Product Features

Series Volume Number
Vol. 15
Lc Classification Number
Rs57.S8 2005
Edition Description
Revised Edition,Expanded,New Edition
Edition Number
3
Table of Content
Introduction to the Evolution of Pharmaceutical Products; C. Ralph Buncher and Jia-Yeong Tsay Statistical Review and Evaluation of Animal Carcinogenicity Studies; Karl K. Lin and Mirza W. Ali The FDA and the IND/NDA Statistical Review Process; Satya D. Dubey, George Y. H. Chi, and Roswitha E. Kelly Clinical Trial Designs; C. Ralph Buncher and Jia-Yeong Tsay Selecting Patients for a Clinical Trial; C. Ralph Buncher and Jia-Yeong Tsay Statistical Aspects of Cancer Clinical Trials; T. Timothy Chen Recent Statistical Issues and Developments in Cancer Clinical Trials; Weichung Joe Shih Design and Analysis of Testosterone Replacement Therapy Trials; Ted M. Smith Clinical Trials of Analgesic Drugs; Cynthia G. McCormick Statistical Issues in HIV/AIDS Research; Ronald J. Bosch and C. Ralph Buncher The Wonders of Placebo; C. Ralph Buncher Active-Controlled Noninferiority/Equivalence Trials: Methods and Practice; Irving K. Hwang Interim Analysis and Bias in Clinical Trials: The Adaptive Design Perspective; Qing Liu and Gordon Pledger Interim Analysis and Adaptive Design in Clinical Trials; Irving K. Hwang and K. K. Gordon Lan A Regulatory Perspective on Data Monitoring and Interim Analysis; Robert T. O'Neill Complex Adaptive Systems, Human Health and Drug Response: Statistical Challenges in Pharmacogenomics; Kim E. Zerba and C. Frank Shen Phase IV Postmarketing Studies; C. Ralph Buncher and Jia-Yeong Tsay The Role of Contract Research Organizations in Clinical Research in the Pharmaceutical Industry; Roger E. Flora and John Constant Global Harmonization of Drug Development: A Clinical Statistics Perspective; Peter H. van Ewijk, Bernhard Huitfeldt, and Jia-Yeong Tsay Bridging Strategies in Global Drug Development; Mamoru Narukawa and Masahiro Takeuchi Design and Analysis Strategies for Clinical Pharmacokinetic Trials; Lianng Yuh and Yusong Chen Stability Studies of Pharmaceuticals; Yi Tsong, Chi-wan Chen, Wen Jen Chen, Roswitha Kelly, Daphne T. Lin, and Karl K. Lin When and How to Do Multiple Comparisons; Charles W. Dunnett and Charles H. Goldsmith Reference Intervals (Ranges): Distribution-Free Methods vs. Normal Theory; Paul S. Horn and Amadeo J. Pesce Index
Copyright Date
2006
Topic
Probability & Statistics / General, Industries / Pharmaceutical & Biotechnology, Pharmacology
Lccn
2005-043985
Dewey Decimal
615/.1901/072
Intended Audience
College Audience
Dewey Edition
22
Illustrated
Yes
Genre
Business & Economics, Mathematics, Medical

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Picture 1 of 1

Chapman and Hall/CRC Biostatistics Ser.: Statistics in the Pharmaceutical Industry by Jia-Yeong Tsay (2005, Hardcover, Revised edition,Expanded,New Edition)

About this product

Product Information

Product Identifiers

Product Key Features

Dimensions

Additional Product Features

Best Selling in Textbooks

Diagnostic and Statistical Manual of Mental Disorders DSM-5-TR by American Psychiatric Association (2022, Trade Paperback)

Desk Reference to the Diagnostic Criteria from DSM-5-TR by American Psychiatric Association (2022, Trade Paperback)

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Leadership : Theory and Practice by Peter G. Northouse (2021, Trade Paperback, Revised edition)

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Diagnostic and Statistical Manual of Mental Disorders : DSM-5-TR by American Psychiatric Association (2022, Hardcover)

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Diagnostic and Statistical Manual of Mental Disorders DSM-5-TR Brand new

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