Monte Carlo Simulation for the Pharmaceutical Industry

Mark Chang is the executive director of biostatistics and data management at AMAG Pharmaceuticals in Lexington, Massachusetts. Dr. Chang is an elected fellow of the American Statistical Association. He is the author of the best-selling Adaptive Design Theory and Implementation Using SAS and R and co-author of the best-selling Adaptive Design Methods in Clinical Trials.

• Simulation, Simulation Everywhere. Virtual Sampling Techniques. Overview of Drug Development. Meta-Simulation for Pharmaceutical Industry. Macro-Simulation for Pharmaceutical R & D. Clinical Trial Simulation (CTS). Clinical Trial Management and Execution. Prescription Drug Commercialization. Molecular Design and Simulation. Disease Modeling and Biological Pathway Simulation. Pharmacokinetic Simulation. Pharmacodynamic Simulation. Monte Carlo for Inference and Beyond. Appendices. Afterword. Bibliography.

"Overall, the book does not only cover a very broad range of different topics but manages to explain these coherently. … this book is not only of interest for scientists in the pharmaceutical industry but also for academia due to its thorough presentation."—Frank Emmert-Streib, Statistical Methods in Medical Research, 21(6), 2012"… well written and easy to read. … this book is worthwhile reading as a long introduction to Monte Carlo simulation and its eventual application in pharmaceutical industry. It can convince people to consider this methodology …"—Sophie Donnet, International Statistical Review, 2012"This is an ambitious book covering a very wide array of topics … the theoretical presentation is reliable and sophisticated … the ability of the author to condense such a broad array of topics, and to present them in a cohesive manner, is quite impressive, and means that the book will contain information of relevance to a wide audience. … Many statisticians working in the pharmaceutical industry will benefit from having access to a copy of this book. Some statisticians working outside the industry may also benefit from having access to a copy, particularly those working in areas overlapping with the pharmaceutical industry, such as clinical science and health economics."—Ian C. Marschner, Australian & New Zealand Journal of Statistics, 2011"For industry statisticians, scientists, and software engineers and programmers, Chang, who works for a pharmaceutical company, details concepts, theories, algorithms, and case studies for carrying out computer simulations in the drug development process, from drug discovery to clinical trial aspects to commercialization. He covers analogy and simulation using examples from different areas, general sampling methods and the different stages of drug development, simulation approaches based on game theory and the Markov decision process, simulations in classical and adaptive trials, and challenges in clinical trial management and execution. He then addresses prescription drug marketing strategies and brand planning, molecular design and simulation, computational systems biology and biological pathway simulation with Petri nets, and physiologically based pharmacokinetic modeling and pharmacodynamic models, ending with Monte Carlo computing techniques for statistical inference."—SciTech Book News, February 2011