Theory of Drug Development presents a formal quantitative framework for understanding drug development that goes beyond simply describing the properties of the statistics in individual studies. It examines the drug development process from the perspectives of drug companies and regulatory agencies.

By quantifying various ideas underlying drug development, the book shows how to systematically address problems, such as:


Sizing a phase 2 trial and choosing the range of p-values that will trigger a follow-up phase 3 trial
Deciding whether a drug should receive marketing approval based on its...