New Drug Development: Design, Methodology, and AnalysisJohn Wiley & Sons, 27. jul. 2007 - 270 sider 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. |
Indhold
Design Methodology and Analysis PART III DESIGN METHODOLOGY AND ANALYSIS | 59 |
Design Methodology and Analysis PART IV LIFECYCLE CLINICAL DEVELOPMENT | 137 |
Design Methodology and Analysis Appendix Additional Resources for Training Executives and Professors | 241 |
Design Methodology and Analysis References | 245 |
259 | |
Design Methodology and Analysis About the Author | 271 |
Almindelige termer og sætninger
addressed administered adverse events ANOVA antihypertensive assessment bioinformatics biological biopharmaceuticals blood pressure calculated cells Chapter clinical development clinical research clinical study clinical trials clinicians compelling evidence conducted considerations context discussed dose treatment group drug development drug discovery drug molecule drug products drug treatment group drug's effect size efficacy endpoints ethical evaluation evidence-based medicine experimental 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 pharmacogenomics pharmacokinetics pharmacological Piantadosi placebo placebo treatment group population 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 t-test target receptor test statistic treatment effect treatment group mean Type I error typically variables variance Wiley & Sons