Theory of Drug Development

This book focuses on the efficient development of drugs and the quantification of evidence in drug development. It presents a formal quantitative framework for understanding drug development that goes beyond simply describing the properties of the statistics in individual studies. Examining the drug development process from the perspectives of both drug companies and regulatory agencies, the author provides a rationale for underpowered phase 2 trials based on the notion of efficiency and develops a framework for evaluating the strength of evidence generated by clinical trials.