Statistical issues in drug development
By: Stephen Senn.
Edition: 2nd ed.
Series: Statistics in practice
Publisher: John Wiley & Sons
Published: 2007
Place of publication: Chichester, England; Hoboken, NJ
Language: eng
Number of pages: 498
ISBN-13: 9780470018774
Subjects: Drug development -- Statistical methods.; Clinical Trials as Topic.; Drug Design.; Statistics as Topic -- methods.
Notes: Includes bibliographical references and index.
Table of contents: value: A brief and superficial history of statistics for drug developers; value: Design and interpretation of clinical trials as seen by a statistician; value: Probability, Bayes, P-values, tests of hypotheses, and confidence intervals; value: The work of the pharmaceutical statistician; value: Allocating treatments to patients in clinical trials; value: Baselines and covariate information; value: The measurement of treatment effects; value: Demographic subgroups : representation and analysis; value: Multiplicity; value: Intention to treat, missing data and related matters; value: One-sided and two-sided tests and other issues to do with significance and P-values; value: Determining the sample size; value: Multicentre trials; value: Active control equivalence studies; value: Meta-analysis; value: Cross-over trials; value: n-of-1 trials; value: Sequential trials; value: Dose-finding; value: Concerning pharmacokinetics and pharmacodynamics; value: Bioequivalence studies; value: Safety data, harms, drug monitoring, and pharmaco-epidemiology; value: Pharmaco-economics and portfolio management; value: Concerning pharmacogenetics, pharmacogenomics, and related matters.