| Document Type
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BL
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| Record Number
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845416
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| Main Entry
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Buncher, C. Ralph.
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| Title & Author
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Statistics in the Pharmaceutical Industry
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| Edition Statement
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3rd ed.
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| Publication Statement
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Boca Raton :: Chapman and Hall/CRC,, 2018.
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| Series Statement
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Chapman and Hall/CRC Biostatistics Ser. ;; v. Vol. 15
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| Page. NO
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1 online resource (497 pages)
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| ISBN
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142005645X
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: 9781420056457
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| Contents
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Cover; Half Title; Title Page; Copyright Page; Dedication; Series Introduction; Preface to the Third Edition; Preface to the Second Edition; Preface to the First Edition; Contributors; Table of Contents; Chapter 1 Introduction to the Evolution of Pharmaceutical Products; Chapter 2 Statistical Review and Evaluation of Animal Carcinogenicity Studies of Pharmaceuticals; Chapter 3 The FDA and the IND/NDA Statistical Review Process; Chapter 4 Clinical Trial Designs; Chapter 5 Selecting Patients for a Clinical Trial; Chapter 6 Statistical Aspects of Cancer Clinical Trials
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Chapter 15 A Regulatory Perspective on Data Monitoring and Interim AnalysisChapter 16 Complex Adaptive Systems, Human Health, and Drug Response: Statistical Challenges in Pharmacogenomics; Chapter 17 Phase IV Postmarketing Studies; Chapter 18 The Role of Contract Research Organizations in Clinical Research in the Pharmaceutical Industry; Chapter 19 Global Harmonization of Drug Development -- A Clinical Statistics Perspective; Chapter 20 Bridging Strategies in Global Drug Development; Chapter 21 Design and Analysis Strategies for Clinical Pharmacokinetic Trials
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Chapter 22 Stability Studies of PharmaceuticalsChapter 23 When and How to Do Multiple Comparisons; Chapter 24 Reference Intervals (Ranges): Distribution-Free Methods vs. Normal Theory; Index
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Chapter 7 Recent Statistical Issues and Developments in Cancer Clinical TrialsChapter 8 Design and Analysis of Testosterone Replacement Therapy Trials; Chapter 9 Clinical Trials of Analgesic Drugs; Chapter 10 Statistical Issues in HIV/AIDS Research; Chapter 11 The Wonders of Placebo; Chapter 12 Active-Controlled Noninferiority/Equivalence Trials: Methods and Practice; Chapter 13 Interim Analysis and Bias in Clinical Trials: The Adaptive Design Perspective; Chapter 14 Interim Analysis and Adaptive Design in Clinical Trials
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| Dewey Classification
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615/.1901/072
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| LC Classification
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RS57.S8 2005
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| Added Entry
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Tsay, Jia-Yeong.
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