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Statistics in the Pharmaceutical Industry Book

Statistics in the Pharmaceutical Industry
Statistics in the Pharmaceutical Industry, 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 compl, Statistics in the Pharmaceutical Industry has a rating of 3 stars
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Statistics in the Pharmaceutical Industry, 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 compl, Statistics in the Pharmaceutical Industry
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  • Statistics in the Pharmaceutical Industry
  • Written by author C. Ralph Buncher
  • Published by Taylor & Francis, Inc., September 2005
  • 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 compl
  • The pharmaceutical industry has a complex relationship with the study and application of statistics: on the one hand, success in the marketplace and in the development and approval processes depends largely on statistical analysis, and software is making
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Book Categories

Authors

Ch. 1Introduction to the evolution of pharmaceutical products1
Ch. 2Statistical review and evaluation of animal carcinogenicity studies of pharmaceuticals17
Ch. 3The FDA and the IND/NDA statistical review process55
Ch. 4Clinical trial designs79
Ch. 5Selecting patients for a clinical trial91
Ch. 6Statistical aspects of cancer clinical trials115
Ch. 7Recent statistical issues and developments in cancer clinical trials135
Ch. 8Design and analysis of testosterone replacement therapy trials151
Ch. 9Clinical trials of analgesic drugs161
Ch. 10Statistical issues in HIV/AIDS research173
Ch. 11The wonders of placebo183
Ch. 12Active-controlled noninferiority/equivalence trials : methods and practice193
Ch. 13Interim analysis and bias in clinical trials : the adaptive design perspective231
Ch. 14Interim analysis and adaptive design in clinical trials245
Ch. 15A regulatory perspective on data monitoring and interim analysis285
Ch. 16Complex adaptive systems, human health, and drug response : statistical challenges in pharmacogenomics295
Ch. 17Phase IV postmarketing studies303
Ch. 18The role of contract research organizations in clinical research in the pharmaceutical industry315
Ch. 19Global harmonization of drug development - a clinical statistics perspective325
Ch. 20Bridging strategies in global drug development345
Ch. 21Design and analysis strategies for clinical pharmacokinetic trials357
Ch. 22Stability studies of pharmaceuticals391
Ch. 23When and how to do multiple comparisons421
Ch. 24Reference intervals (ranges) : distribution-free methods vs. normal theory453


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