Statistical issues in drug development
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Main Authors: | |
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Published: |
John Wiley & Sons,
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Publisher Address: | Chichester, England Hoboken, NJ |
Publication Dates: | c2007. |
Literature type: | Book |
Language: | English |
Edition: | 2nd ed. |
Series: |
Statistics in practice |
Subjects: | |
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. |