| Description |
xix, 498 pages : illustrations ; 25 cm |
| Series |
Statistics in practice |
|
Statistics in practice.
|
| Contents |
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 |
| Summary |
"Statistical Issues in Drug Development presents an essential and thought provoking guide to the statistical issues and controversies involved in drug development. This second edition has been updated to include: Comprehensive coverage of the design and interpretation of clinical trials; Expanded sections on missing data, equivalence, meta-analysis and dose finding; An examination of both Bayesian and frequentist methods; A new chapter on pharmacogenomics and expanded coverage of pharmaco-epidemiology and pharmaco-economics; Coverage of the ICH guidelines, in particular ICH E9, Statistical Principles for Clinical Trials." |
|
"It is hoped that the book will stimulate dialogue between statisticians and life scientists working within the pharmaceutical industry. The accessible and wide-ranging coverage make it essential reading for both statisticians and non-statisticians working in the pharmaceutical industry, regulatory bodies and medical research institutes. There is also much to benefit undergraduate and postgraduate students whose courses include a medical statistics component."--BOOK JACKET |
| Bibliography |
Includes bibliographical references and index |
| Subject |
Drug development -- Statistical methods.
|
|
Clinical Trials as Topic.
|
|
Drug Design.
|
|
Statistics as Topic -- methods.
|
| LC no. |
2007045553 |
| ISBN |
9780470018774 cloth alkaline paper |
|
0470018771 cloth alkaline paper |
|
