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Statistical issues in drug development

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Bibliographic Details
Main Authors: Senn Stephen.
Published: John Wiley & Sons,
Publisher Address: Chichester, England Hoboken, NJ
Publication Dates: c2007.
Literature type: Book
Language: English
Edition: 2nd ed.
Series: Statistics in practice
Subjects:
Drug development > Statistical methods.
Clinical Trials as Topic.
Drug Design.
Statistics as Topic > methods.
Médicaments > Développement > Méthodes statistiques.
Carrier Form: xix, 498 p.: ill. ; 25 cm.
ISBN: 9780470018774 (cloth : alk. paper)
0470018771 (cloth : alk. paper)
Index Number: TQ46
CLC: TQ46-37
Call Number: TQ46-37/S478/2nd.ed.
Contents: Includes bibliographical references and index.
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.

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