TY - BOOK AU - Senn,Stephen ED - ebrary, Inc. TI - Statistical issues in drug development T2 - Statistics in practice AV - RM301.25 .S46 2007eb U1 - 615/.190727 22 PY - 2007/// CY - Chichester, England, Hoboken, NJ PB - John Wiley & Sons KW - Drug development KW - Statistical methods KW - Electronic books KW - local N1 - 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 UR - http://site.ebrary.com/lib/rucke/Doc?id=10232744 ER -