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Book Cover
Author Senn, Stephen.

Title Statistical issues in drug development / Stephen Senn
Edition Second edition
Published Chichester, England ; Hoboken, NJ : John Wiley & Sons, [2007]
Online access available from:
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Description 1 online resource (xix, 498 pages) : illustrations
Series Statistics in practice
Statistics in practice.
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
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
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
Summary Drug development is the process of finding and producing therapeutically useful pharmaceuticals, turning them into safe and effective medicine, and producing reliable information regarding the appropriate dosage and dosing intervals. With regulatory authorities demanding increasingly higher standards in such developments, statistics has become an intrinsic and critical element in the design and conduct of drug development programmes. Statistical Issues in Drug Development presents an essential and thought provoking guide to the statistical issues and controversies involved in drug development
Bibliography Includes bibliographical references and index
Notes Print version record
Subject Drug development -- Statistical methods.
Clinical Trials as Topic.
Drug Design.
Statistics as Topic -- methods.
Form Electronic book
LC no. 2007045553
ISBN 0470723572 (electronic bk.)
9780470723579 (electronic bk.)
(cloth ; alk. paper)
(cloth ; alk. paper)