This edition includes both updates and new uses and issues concerning CTS along with case
studies of how clinical trial simulations are being applied in various therapeutic and
application areas. Importantly the book expands on the utility of CTS for informing decisions
during drug development and regulatory review. Each chapter author was selected on the basis of
demonstrated expertise in state-of-the-art application of CTS. The target audience for this
volume includes researchers and scientists who wish to consider use of simulations in the
design analysis or regulatory review and guidance of clinical trials. This book does not
embrace all aspects of trial design nor is it intended as a complete recipe for using
computers to design trials. Rather it is an information source that enables the reader to gain
understanding of essential background and knowledge for practical applications of simulation
for clinical trial design and analysis. It is assumed that the reader has a working
understanding of pharmacokinetics and pharmacodynamics modeling pharmacometric analyses and
or the drug development and regulatory processes.
