This book focuses on important decision points and evidence needed for making decisions at these points during the development of a new drug. It takes a holisti

This contributed volume presents an overview of concepts, methods, and applications used in several quantitative areas of drug research, development, and market

State-of-the-Art Methods for Drug Safety Assessment Responding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Dr

Platform trials test multiple therapies in one indication, one therapy for multiple indications, or both. These novel clinical trial designs can dramatically in