Statistical issues in drug development [electronic resource] /
Stephen Senn.
- 2nd ed.
- Chichester, England ; Hoboken, NJ : John Wiley, c2007.
- xix, 498 p. : ill. ; 25 cm.
- Statistics in practice .
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.
Electronic reproduction. Palo Alto, Calif. : ebrary, 2009. Available via World Wide Web. Access may be limited to ebrary affiliated libraries.