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Statistics in the Pharmaceutical Industry Book

Statistics in the Pharmaceutical Industry
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Statistics in the Pharmaceutical Industry, Updated and expanded to reflect the most recent trends and challenges in pharmaceutical statistics, this third edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies. This approach provides insight into the, Statistics in the Pharmaceutical Industry
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  • Statistics in the Pharmaceutical Industry
  • Written by author C. Ralph Buncher, Jia-Yeong Tsay
  • Published by Marcel Dekker Inc, 1993/11/17
  • Updated and expanded to reflect the most recent trends and challenges in pharmaceutical statistics, this third edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies. This approach provides insight into the
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Authors

Ch. 1 Introduction to the evolution of pharmaceutical products 1
Ch. 2 Statistical review and evaluation of animal carcinogenicity studies of pharmaceuticals 17
Ch. 3 The FDA and the IND/NDA statistical review process 55
Ch. 4 Clinical trial designs 79
Ch. 5 Selecting patients for a clinical trial 91
Ch. 6 Statistical aspects of cancer clinical trials 115
Ch. 7 Recent statistical issues and developments in cancer clinical trials 135
Ch. 8 Design and analysis of testosterone replacement therapy trials 151
Ch. 9 Clinical trials of analgesic drugs 161
Ch. 10 Statistical issues in HIV/AIDS research 173
Ch. 11 The wonders of placebo 183
Ch. 12 Active-controlled noninferiority/equivalence trials : methods and practice 193
Ch. 13 Interim analysis and bias in clinical trials : the adaptive design perspective 231
Ch. 14 Interim analysis and adaptive design in clinical trials 245
Ch. 15 A regulatory perspective on data monitoring and interim analysis 285
Ch. 16 Complex adaptive systems, human health, and drug response : statistical challenges in pharmacogenomics 295
Ch. 17 Phase IV postmarketing studies 303
Ch. 18 The role of contract research organizations in clinical research in the pharmaceutical industry 315
Ch. 19 Global harmonization of drug development - a clinical statistics perspective 325
Ch. 20 Bridging strategies in global drug development 345
Ch. 21 Design and analysis strategies for clinical pharmacokinetic trials 357
Ch. 22 Stability studies of pharmaceuticals 391
Ch. 23 When and how to do multiple comparisons 421
Ch. 24 Reference intervals (ranges) : distribution-free methods vs. normal theory 453


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Statistics in the Pharmaceutical Industry, Updated and expanded to reflect the most recent trends and challenges in pharmaceutical statistics, this third edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies. This approach provides insight into the, Statistics in the Pharmaceutical Industry

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Statistics in the Pharmaceutical Industry, Updated and expanded to reflect the most recent trends and challenges in pharmaceutical statistics, this third edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies. This approach provides insight into the, Statistics in the Pharmaceutical Industry

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Statistics in the Pharmaceutical Industry, Updated and expanded to reflect the most recent trends and challenges in pharmaceutical statistics, this third edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies. This approach provides insight into the, Statistics in the Pharmaceutical Industry

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