Document Type
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BL
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Record Number
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656747
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Doc. No
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dltt
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Main Entry
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Senn, Stephen
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Title & Author
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Statistical issues in drug development /\ Stephen Senn
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Edition Statement
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2nd ed
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Publication Statement
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Chichester, England ;Hoboken, NJ :: John Wiley & Sons,, c2007
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Series Statement
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Statistics in practice
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Page. NO
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xix, 498 p. :: ill. ;; 25 cm
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ISBN
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9780470018774 (cloth : alk. paper)
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: 0470018771 (cloth : alk. paper)
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Bibliographies/Indexes
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Includes bibliographical references and index
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Contents
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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 --
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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 --
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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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Subject
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Drug development-- Statistical methods
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Subject
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Clinical Trials as Topic
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Subject
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Drug Design
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Subject
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Statistics as Topic-- methods
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Dewey Classification
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615/.190727
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LC Classification
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RM301.25.S46 2007
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RM301.25.S46 2007
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NLM classification
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2008 B-684
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QV 771S478s 2007
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