An Introduction To Statistics In Early Phase Trials Steven A Julious by Steven A. Julious, Say Beng Tan, David Machin(auth.) 9780470059852, 9780470686164, 0470059850, 0470686162 instant download after payment.

All new medicines and devices undergo early phase trials to assess, interpret and better understand their efficacy, tolerability and safety. An Introduction to Statistics in Early Phase Trials describes the practical design and analysis of these important early phase clinical trials and provides the crucial statistical basis for their interpretation. It clearly and concisely provides an overview of the most common types of trials undertaken in early phase clinical research and explains the different methodologies used. The impact of statistical technologies on clinical development and the statistical and methodological basis for making clinical and investment decisions are also explained.

• Conveys key ideas in a concise manner understandable by non-statisticians
• Explains how to optimise designs in a constrained or fixed resource setting
• Discusses decision making criteria at the end of Phase II trials
• Highlights practical day-to-day issues and reporting of early phase trials

An Introduction to Statistics in Early Phase Trials is an essential guide for all researchers working in early phase clinical trial development, from clinical pharmacologists and pharmacokineticists through to clinical investigators and medical statisticians. It is also a valuable reference for teachers and students of pharmaceutical medicine learning about the design and analysis of clinical trials.Content:
Chapter 1 Early Phase Trials (pages 1–12):
Chapter 2 Introduction to Pharmacokinetics (pages 13–35):
Chapter 3 Sample Size Calculations for Clinical Trials (pages 37–53):
Chapter 4 Crossover Trial Basics (pages 55–69):
Chapter 5 Multi?Period Crossover Trials (pages 71–85):
Chapter 6 First Time into Man (pages 87–111):
Chapter 7 Bayesian and Frequentist Methods (pages 113–124):
Chapter 8 First?Time?into?New?Population Studies (pages 125–138):
Chapter 9 Bioequivalence Studies (pages 139–167):
Chapter 10 Other Phase I Trials (pages 169–185):
Chapter 11 Phase II Trials: General Issues (pages 187–196):
Chapter 12 Dose–Response Studies (pages 197–210):
Chapter 13 Phase II Trials with Toxic Therapies (pages 211–222):
Chapter 14 Interpreting and Applying Early Phase Trial Results (pages 223–230):
Chapter 15 Go/No?Go Criteria (pages 231–244):