New Drug Development: Design, Methodology, and Analysis
John Wiley & Sons, 27 Tem 2007 - 270 sayfa
This book acquaints students and practitioners in the related fields of pharmaceutical sciences, clinical trials, and evidence-based medicine with the necessary study design concepts and statistical practices to allow them to understand how drug developers plan and evaluate their drug development. Two goals of the book are to make the material accessible to readers with minimal background in research and to be straightforward enough for self-taught purposes. By bringing the topic from the early discovery phase to clinical trials and medical practice, the book provides an indispensable overview of an otherwise confusing and fragmented set of topics. The author’s experience as a respected scientist, teacher of statistics, and one who has worked in the clinical trials arena makes him well suited to write such a treatise.
Kullanıcılar ne diyor? - Eleştiri yazın
Her zamanki yerlerde hiçbir eleştiri bulamadık.
The Regulatory Environment for New Drug Development
Design and Methodology in Clinical Trials
Employment of Hypothesis Testing
Employment of Confidence Intervals
Safety Assessment in Clinical Trials
Efficacy Assessment in Clinical Trials
Pharmaceutical and Biopharmaceutical Drug Manufacturing
Unifying Themes and Concluding Comments
APPENDIX Additional Resources For Training Executives and Professors
20-mg dose treatment addressed administered adverse events ANOVA antihypertensive assessment bioinformatics biological biopharmaceuticals blood pressure calculated cells Chapter clinical development clinical research clinical study clinical trials clinicians coefficient of determination compelling evidence conducted considerations context discussed dose treatment group drug development drug discovery drug molecule drug treatment group drug's effect size efficacy endpoints ethical evaluation hypothesis testing important interaction interim analysis investigational drug manufacturing metabolism methodology mmHg molecular nonclinical nonclinical studies noninferiority null hypothesis number of subjects optimum quality data p-value patients pharmaceutical pharmacodynamic pharmacokinetic pharmacological placebo placebo treatment group population postmarketing surveillance proteins randomized regulatory agencies reject the null research question Rick Turner safety data sample sample-size estimation sponsor statistical analysis statistical significance study design study protocol superiority trials target receptor test statistic treatment effect treatment group mean Type I error Type II error typically variables variance