This rewritten and updated second edition provides comprehensive information on the wide-ranging applications of statistics in the pharmacological field. Focusing on practical aspects, it sets out to bridge the gap between industry and academia.;Reflecting the changes that have taken place since publication of the first edition, this volume covers new topics such as: cancer clinical trials, clinical trials of AIDS patients and animal tumorigenicity studies; the development of antiepileptic drugs; the role of epidemiology in postmarketing trials and adverse drug experience; computer-assisted new drug application (CANDA) submissions; contract research organizations; interim analysis in clinical trials; and room-temperature tests for the stability of drugs.;This work is intended as: a reference for statisticians, biostatisticians, pharmacologists, administrators, managers, and scientists in the pharmaceutical industry; and a text for graduate students taking courses in applied statistics or pharmaceutical statistics.
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1 of 4 people found the following review helpful:
4.0 out of 5 stars
excellent collection of articles,
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This review is from: Statistics In the Pharmaceutical Industry, 3rd Edition (Chapman & Hall/CRC Biostatistics Series) (Hardcover)
This is a very nice collection of real world examples from the pharmaceutical industry. There are many articles here that any biostatistician in the pharmaceutical industry would find fascinating. In fact one of my former bosses, Ted Smith from Auxilium Pharmaceuticals Inc, wrote an article about testosterone supplements. Auxilium markets Testim a testosterone gel that is used as a supplement for older men with low levels of testosterone in their system.
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Inside This Book
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First Sentence:
Excitement is the descriptive word for the pharmaceutical industry today. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
animal tumorigenicity studies, overall false positive error, reviewing pharmacologists, average correlation measures, tumor prevalence rates, expiration dating period, group sequential boundaries, comparative bioavailability trials, flank pain syndrome, antitumor screen, log potency, formal interim analyses, screening investigator, mean degradation curve, data management plan, prevalence method, statistical reviewers, incidental tumors, tumor incidence rates, fatal context, tumorigenicity experiments, parallel line assay, group sequential methods, slope ratio assay, intercurrent mortality Key Phrases - Capitalized Phrases (CAPs): (learn more)
New York, United States, Marcel Dekker, American Statistical Association, Division of Biometrics, Epilepsy Branch, Federal Register, John Wiley, National Cancer Institute, Code of Federal Regulations, Contract Research Organizations, National Institutes of Health, New Jersey, Total Quality Control, Monte Carlo, Raven Press, Academic Press, Charles River Company, Collaborative Group, Comparative Pathology, Institutional Review Board, Label True Mean, Oxford University Press, Review Project, Staff College New!
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Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Excitement is the descriptive word for the pharmaceutical industry today. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
animal tumorigenicity studies, overall false positive error, reviewing pharmacologists, average correlation measures, tumor prevalence rates, expiration dating period, group sequential boundaries, comparative bioavailability trials, flank pain syndrome, antitumor screen, log potency, formal interim analyses, screening investigator, mean degradation curve, data management plan, prevalence method, statistical reviewers, incidental tumors, tumor incidence rates, fatal context, tumorigenicity experiments, parallel line assay, group sequential methods, slope ratio assay, intercurrent mortality Key Phrases - Capitalized Phrases (CAPs): (learn more)
New York, United States, Marcel Dekker, American Statistical Association, Division of Biometrics, Epilepsy Branch, Federal Register, John Wiley, National Cancer Institute, Code of Federal Regulations, Contract Research Organizations, National Institutes of Health, New Jersey, Total Quality Control, Monte Carlo, Raven Press, Academic Press, Charles River Company, Collaborative Group, Comparative Pathology, Institutional Review Board, Label True Mean, Oxford University Press, Review Project, Staff College New!
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Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Citations (learn more)
This book cites 100
books:
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100
books
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- Statistical Issues in Drug Research and Development (Statistics: A Series of Textbooks and Monographs) by Karl E. Peace in Front Matter, page 179, and page 206
- Data Quality Control and Editing (Statistics, textbooks and monographs ; v. 10) by Joseph I. Naus in Front Matter, and page 364
- Statistics and Society (Statistics: A Series of Textbooks and Monographs) by Federer in Front Matter (1), and Front Matter (2)
- Introduction to Probability and Statistics, 2nd Edition (Statistics: A Series of Textbooks and Monographs) by Narayan C. Giri in Front Matter (1), and Front Matter (2)
- Statistical Methods for Engineers and Scientists (Statistics: A Series of Textbooks and Monographs) by Robert M. Bethea in Front Matter (1), and Front Matter (2)
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- Drug Safety Assessment in Clinical Trials (Statistics: A Series of Textbooks and Monographs) by Gilbert on 4 pages
- Statistical Issues in Drug Research and Development (Statistics: A Series of Textbooks and Monographs) by Karl E. Peace on 4 pages
- Biopharmaceutical Sequential Statistical Applications (Statistics: A Series of Textbooks and Monographs) by Karl E. Peace in Front Matter, page 13, and page 232
- Statistical Design and Analysis in Pharmaceutical Science ( Vol 143 ) (Statistics: A Series of Textbooks and Monographs) by Shein-Chung Chow in Front Matter (1), Front Matter (2), and Back Matter
- Design and Analysis of Clinical Trials: Concept and Methodologies (Wiley Series in Probability and Statistics) by Shein-Chung Chow in Back Matter (1), Back Matter (2), and Back Matter (3)
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