Senn, Stephen.
Statistical issues in drug development [electronic resource] / Stephen Senn. - 2nd ed. - Chichester, England ; Hoboken, NJ : John Wiley & Sons, c2007. - xix, 498 p. : ill. - Statistics in practice . - 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,
2013.
Available via World Wide Web.
Access may be limited to ebrary affiliated libraries.
DNLM
Drug development--Statistical methods.
Electronic books.
RM301.25 / .S46 2007eb
615/.190727
Statistical issues in drug development [electronic resource] / Stephen Senn. - 2nd ed. - Chichester, England ; Hoboken, NJ : John Wiley & Sons, c2007. - xix, 498 p. : ill. - Statistics in practice . - 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,
2013.
Available via World Wide Web.
Access may be limited to ebrary affiliated libraries.
DNLM
Drug development--Statistical methods.
Electronic books.
RM301.25 / .S46 2007eb
615/.190727