Short description This guide offers an overview of the most common types of trial undertaken in early clinical development. The coverage discusses the different methodologies and the impact of new technologies, both clinical and statistical, on clinical development. It also describes how information at the end of early phase development can be brought together to facilitate and enhance decisions pertinent to a clinical development program. This is an essential resource for both researchers working in early phase trials and students of pharmaceutical medicine.
From the contents Chapter 1 Early phase trials
Chapter 2 Introduction to pharmacokinetics
Chapter 3 Sample size calculations for clinical trials
Chapter 4 Crossover trial basics
Chapter 5 Multi-period crossover trials
Chapter 6 First time into man
Chapter 7 Bayesian and frequentist methods
Chapter 8 First-time-into-new-population studies
Chapter 9 Bioequivalence studies
Chapter 10 Other Phase I trials
Chapter 11 Phase II trials: general issues
Chapter 12 Dose-response studies
Chapter 13 Phase II trials with toxic therapies
Chapter 14 Interpreting and applying early phase trial results
