Statistical issues in drug development
著者
書誌事項
Statistical issues in drug development
（Statistics in practice）
J. Wiley, c1997
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内容説明・目次
内容説明
The statistical issues in drug development are explained in this book, enabling non-statistians to work more easily alongside their statistical colleagues in planning, analysing and interpreting clinical trials. The author aims to make the book of particularly benefit to the physician who might have little access to statistical expertise. Drug development brings its own commercial pressures whilst regulatory standards determine that much of the work is examined very closely. As a consequence, the non-statistician working in drug development has to possess considerable appreciation of statistical issues, and this book aims to provide that.
目次
- Section 1: A brief history of statistics
- design and interpretation of clinical trials as seen by a statistician
- probability, Bayes and p-values
- the work of the statistician. Section 2 - (controversial topics in drug development): allocating treatment to patients in clinical trials
- using covariate information
- sub-group analysis
- the problem of multiplicity
- concerning intention to treat
- one sided and two sided tests
- determining sample size
- active control equivalence studies
- multi-centre trials and meta-analysis
- sequential trials
- cross-over trials
- n-of-1 trials
- dose-finding
- bioequivalence studies
- pharmacokinetic studies
- project prioritisation
- statistical problems in drug monitoring.
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