Statistics in the pharmaceutical industry

✍ Scribed by Buncher, Charles Ralph; Tsay, Jia-Yeong

Publisher: CRC Press
Year: 2019
Tongue: English
Leaves: 497
Series: Biostatistics
Edition: 3rd ed
Category: Library

No coin nor oath required. For personal study only.

✦ Table of Contents

Content: Introduction to the Evolution of Pharmaceutical Products
&lt
i&gt
C. Ralph Buncher and Jia-Yeong Tsay&lt
/i&gt
&lt
br&gt
Statistical Review and Evaluation of Animal Carcinogenicity Studies
&lt
i&gt
Karl K. Lin and Mirza W. Ali&lt
/i&gt
&lt
br&gt
The FDA and the IND/NDA Statistical Review Process
&lt
i&gt
Satya D. Dubey, George Y. H. Chi, and Roswitha E. Kelly&lt
/i&gt
&lt
br&gt
Clinical Trial Designs
&lt
i&gt
C. Ralph Buncher and Jia-Yeong Tsay&lt
/i&gt
&lt
br&gt
Selecting Patients for a Clinical Trial
&lt
i&gt
C. Ralph Buncher and Jia-Yeong Tsay&lt
/i&gt
&lt
br&gt
Statistical Aspects of Cancer Clinical Trials
&lt
i&gt
T. Timothy Chen&lt
/i&gt
&lt
br&gt
Recent Statistical Issues and Developments in Cancer Clinical Trials
&lt
i&gt
Weichung Joe Shih&lt
/i&gt
&lt
br&gt
Design and Analysis of Testosterone Replacement Therapy Trials
&lt
i&gt
Ted M. Smith&lt
/i&gt
&lt
br&gt
Clinical Trials of Analgesic Drugs
&lt
i&gt
Cynthia G. McCormick&lt
/i&gt
&lt
br&gt
Statistical Issues in HIV/AIDS Research
&lt
i&gt
Ronald J. Bosch and C. Ralph Buncher&lt
/i&gt
&lt
br&gt
The Wonders of Placebo
&lt
i&gt
C. Ralph Buncher&lt
/i&gt
&lt
br&gt
Active-Controlled Noninferiority/Equivalence Trials: Methods and Practice
&lt
i&gt
Irving K. Hwang&lt
/i&gt
&lt
br&gt
Interim Analysis and Bias in Clinical Trials: The Adaptive Design Perspective
&lt
i&gt
Qing Liu and Gordon Pledger&lt
/i&gt
&lt
br&gt
Interim Analysis and Adaptive Design in Clinical Trials
&lt
i&gt
Irving K. Hwang and K. K. Gordon Lan&lt
/i&gt
&lt
br&gt
A Regulatory Perspective on Data Monitoring and Interim Analysis
&lt
i&gt
Robert T. O'Neill&lt
/i&gt
&lt
br&gt
Complex Adaptive Systems, Human Health and Drug Response: Statistical Challenges in Pharmacogenomics
&lt
i&gt
Kim E. Zerba and C. Frank Shen&lt
/i&gt
&lt
br&gt
Phase IV Postmarketing Studies
&lt
i&gt
C. Ralph Buncher and Jia-Yeong Tsay&lt
/i&gt
&lt
br&gt
The Role of Contract Research Organizations in Clinical Research in the Pharmaceutical Industry
&lt
i&gt
Roger E. Flora and John Constant&lt
/i&gt
&lt
br&gt
Global Harmonization of Drug Development: A Clinical Statistics Perspective
&lt
i&gt
Peter H. van Ewijk, Bernhard Huitfeldt, and Jia-Yeong Tsay&lt
/i&gt
&lt
br&gt
Bridging Strategies in Global Drug Development
&lt
i&gt
Mamoru Narukawa and Masahiro Takeuchi&lt
/i&gt
&lt
br&gt
Design and Analysis Strategies for Clinical Pharmacokinetic Trials
&lt
i&gt
Lianng Yuh and Yusong Chen&lt
/i&gt
&lt
br&gt
Stability Studies of Pharmaceuticals
&lt
i&gt
Yi Tsong, Chi-wan Chen, Wen Jen Chen, Roswitha Kelly, Daphne T. Lin, and Karl K. Lin&lt
/i&gt
&lt
br&gt
When and How to Do Multiple Comparisons
&lt
i&gt
Charles W. Dunnett and Charles H. Goldsmith&lt
/i&gt
&lt
br&gt
Reference Intervals (Ranges): Distribution-Free Methods vs. Normal Theory
&lt
i&gt
Paul S. Horn and Amadeo J. Pesce&lt
/i&gt
&lt
h3&gt
Index&lt
/h3&gt

✦ Subjects

Pharmacy;Statistical methods;Pharmaceutical industry;Statistical methods;Drugs;Testing

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