The Resource Statistical issues in drug development, Stephen Senn

Statistical issues in drug development, Stephen Senn

Label
Statistical issues in drug development
Title
Statistical issues in drug development
Statement of responsibility
Stephen Senn
Creator
Subject
Language
eng
Summary
  • "Statistical Issues in Drug Development presents an essential and thought provoking guide to the statistical issues and controversies involved in drug development. This second edition has been updated to include: Comprehensive coverage of the design and interpretation of clinical trials; Expanded sections on missing data, equivalence, meta-analysis and dose finding; An examination of both Bayesian and frequentist methods; A new chapter on pharmacogenomics and expanded coverage of pharmaco-epidemiology and pharmaco-economics; Coverage of the ICH guidelines, in particular ICH E9, Statistical Principles for Clinical Trials."
  • "It is hoped that the book will stimulate dialogue between statisticians and life scientists working within the pharmaceutical industry. The accessible and wide-ranging coverage make it essential reading for both statisticians and non-statisticians working in the pharmaceutical industry, regulatory bodies and medical research institutes. There is also much to benefit undergraduate and postgraduate students whose courses include a medical statistics component."--BOOK JACKET
Cataloging source
DNLM/DLC
Dewey number
615/.190727
Illustrations
illustrations
Index
index present
LC call number
RM301.25
LC item number
.S46 2007
Literary form
non fiction
Nature of contents
bibliography
Series statement
Statistics in practice
Label
Statistical issues in drug development, Stephen Senn
Publication
Bibliography note
Includes bibliographical references and index
http://library.link/vocab/branchCode
  • zbnus
  • glg
Contents
  • A brief and superficial history of statistics for drug developers -- Design and interpretation of clinical trials as seen by a statistician -- Probability, Bayes, P-values, tests of hypotheses, and confidence intervals -- The work of the pharmaceutical statistician -- Allocating treatments to patients in clinical trials -- Baselines and covariate information --
  • The measurement of treatment effects -- Demographic subgroups : representation and analysis -- Multiplicity -- Intention to treat, missing data and related matters -- One-sided and two-sided tests and other issues to do with significance and P-values -- Determining the sample size -- Multicentre trials -- Active control equivalence studies --
  • Meta-analysis -- Cross-over trials -- n-of-1 trials -- Sequential trials -- Dose-finding -- Concerning pharmacokinetics and pharmacodynamics -- Bioequivalence studies -- Safety data, harms, drug monitoring, and pharmaco-epidemiology -- Pharmaco-economics and portfolio management -- Concerning pharmacogenetics, pharmacogenomics, and related matters
Control code
000042368598
Dimensions
25 cm
Edition
2nd ed
Extent
xix, 498 p.
Isbn
9780470018774
Isbn Type
(cloth : alk. paper)
Lccn
2007045553
Other physical details
ill.
http://library.link/vocab/recordID
.b23061881
System control number
  • lt23061881
  • (OCoLC)180907943

Library Locations

    • Deakin University Library - Geelong Waurn Ponds CampusBorrow it
      75 Pigdons Road, Waurn Ponds, Victoria, 3216, AU
      -38.195656 144.304955
    • Deakin University Library - Geelong Waurn Ponds CampusBorrow it
      75 Pigdons Road, Waurn Ponds, Victoria, 3216, AU
      -38.195656 144.304955
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