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Statistical Thinking for Non-Statisticians in Drug Regulation, 2nd Edition - Richard Kay

Statistical Thinking for Non-Statisticians in Drug Regulation, 2nd Edition - Richard Kay

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Author : Richard Kay Language: English Finishing : Hardcover, 376 pages ISBN : 978-1-118-47094-7 Edition Number: 2014 Description: Statistical Thinking for Non-Statisticians in Drug Regulation, Second Edition, is a need-to-know guide to understanding statistical methodology, data and results within drug development and clinical trials for anyone working in the pharmaceutical and medical device industries. This new edition includes four...
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Descripción completa de: Statistical Thinking for Non-Statisticians in Drug Regulation, 2nd Edition - Richard Kay

Author : Richard Kay

Language: English

Finishing : Hardcover, 376 pages

ISBN : 978-1-118-47094-7

Edition Number: 2014

Description:

Statistical Thinking for Non-Statisticians in Drug Regulation, Second Edition, is a need-to-know guide to understanding statistical methodology, data and results within drug development and clinical trials for anyone working in the pharmaceutical and medical device industries. This new edition includes four new chapters covering Bayesian statistics, adaptive designs, observational studies and methods for safety analysis and monitoring.

Table Of Contents:

  • Preface to Second Edition
  • Preface to First Edition
  • Abbreviations
  • 1 Basic ideas in clinical trial design
  • 2 Sampling and inferential statistics
  • 3 Confidence intervals and p-values
  • 4 Tests for simple treatment comparisons
  • 5 Adjusting the analysis
  • 6 Regression and analysis of covariance
  • 7 Intention-to-treat and analysis sets
  • 8 Power and sample size
  • 9 Statistical significance and clinical importance
  • 10 Multiple testing
  • 11 Non-parametric and related methods
  • 12 Equivalence and non-inferiority
  • 13 The analysis of survival data
  • 14 Interim analysis and data monitoring committees
  • 15 Bayesian statistics
  • 16 Adaptive Designs
  • 17 Observational studies
  • 18 Meta-analysis
  • 19 Methods for the Safety Analysis and Safety Monitoring
  • 20 Diagnosis
  • 21 The role of statistics and statisticians
  • References
  • Index

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