Statistical Thinking for Non–Statisticians in Drug Regulation, Second Edition, is a need–to–know guide to understanding statistical methodology, data and results within drug development and clinical trials for anyone working in the pharmaceutical and medical device industries. This new edition includes four new chapters covering Bayesian statistics, adaptive designs, observational studies and methods for safety analysis and monitoring. INDICE: Preface to Second Edition Preface to First Edition Abbreviations 1 Basic ideas in clinical trial design 2 Sampling and inferential statistics 3 Confidence intervals and p–values 4 Tests for simple treatment comparisons 5 Adjusting the analysis 6 Regression and analysis of covariance 7 Intention–to–treat and analysis sets 8 Power and sample size 9 Statistical significance and clinical importance 10 Multiple testing 11 Non–parametric and related methods 12 Equivalence and non–inferiority 13 The analysis of survival data 14 Interim analysis and data monitoring committees 15 Bayesian statistics 16 Adaptive Designs 17 Observational studies 18 Meta–analysis 19 Methods for the Safety Analysis and Safety Monitoring 20 Diagnosis 21 The role of statistics and statisticians References Index
- ISBN: 978-1-118-47094-7
- Editorial: Wiley–Blackwell
- Encuadernacion: Cartoné
- Páginas: 376
- Fecha Publicación: 12/01/2015
- Nº Volúmenes: 1
- Idioma: Inglés