TY  - BOOK
AU  - Senn,Stephen
TI  - Statistical issues in drug development
SN  - 9780470018774 (cloth : alk. paper)
U1  - 615/.190727 
PY  - 2007///
CY  - Chichester, England , Hoboken, NJ
PB  - John Wiley & Sons
KW  - Drug development
KW  - Clinical Trials as Topic
KW  - Drug Design
KW  - Statistics as Topic
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
UR  - http://www.loc.gov/catdir/enhancements/fy0826/2007045553-t.html
UR  - http://www.loc.gov/catdir/enhancements/fy0826/2007045553-d.html
UR  - http://www.loc.gov/catdir/enhancements/fy0833/2007045553-b.html
ER  -