3rd Edition
Statistics In the Pharmaceutical Industry
496 Pages
by
CRC Press
504 Pages
by
CRC Press
504 Pages
by
CRC Press
Also available as eBook on:
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... Read more
Introduction to the Evolution of Pharmaceutical Products. Statistical Review and Evaluation of Animal Carcinogenicity Studies. The FDA and the IND/NDA Statistical Review Process. Clinical Trial Designs. Selecting Patients for a Clinical Trial. Statistical Aspects of Cancer Clinical Trials. Recent Statistical Issues and Developments in Cancer Clinical Trials. Design and Analysis of Testosterone Replacement Therapy Trials. Clinical Trials of Analgesic Drugs. Statistical Issues in HIV/AIDS Research. The Wonders of Placebo. Active-Controlled Noninferiority/Equivalence Trials: Methods and Practice. Interim Analysis and Bias in Clinical Trials: The Adaptive Design Perspective. Interim Analysis and Adaptive Design in Clinical Trials. A Regulatory Perspective on Data Monitoring and Interim Analysis. Complex Adaptive Systems, Human Health and Drug Response: Statistical Challenges in Pharmacogenomics. Phase IV Postmarketing Studies. The Role of Contract Research Organizations in Clinical Research in the Pharmaceutical Industry. Global Harmonization of Drug Development: A Clinical Statistics Perspective. Bridging Strategies in Global Drug Development. Design and Analysis Strategies for Clinical Pharmacokinetic Trials. Stability Studies of Pharmaceuticals. When and How to Do Multiple Comparisons. Reference Intervals (Ranges): Distribution-Free Methods vs. Normal Theory. Index.
Biography
C. Ralph Buncher, Jia-Yeong Tsay
