Table of Contents

Early phase trials.
Introduction to pharmacokinetics.
Sample size calculations for clinical trials.
Crossover trial basics.
Multiperiod crossover trials.
First time into man.
Bayesian and frequentist methods.
First-time-into-new-population studies.
Bioequivalence studies.
Other phase I trials.
Phase II trials : general issues.
Dose/response studies.
Phase II trials with toxic therapies.
Interpreting and applying early phase trial results.
Go/no-go criteria.