Monte Carlo Simulation for the Pharmaceutical Industry: Concepts, Algorithms, and Case Studies, 1st Edition (Paperback) book cover

Monte Carlo Simulation for the Pharmaceutical Industry

Concepts, Algorithms, and Case Studies, 1st Edition

By Mark Chang

CRC Press

564 pages | 116 B/W Illus.

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Description

Helping you become a creative, logical thinker and skillful "simulator," Monte Carlo Simulation for the Pharmaceutical Industry: Concepts, Algorithms, and Case Studies provides broad coverage of the entire drug development process, from drug discovery to preclinical and clinical trial aspects to commercialization. It presents the theories and methods needed to carry out computer simulations efficiently, covers both descriptive and pseudocode algorithms that provide the basis for implementation of the simulation methods, and illustrates real-world problems through case studies.

The text first emphasizes the importance of analogy and simulation using examples from a variety of areas, before introducing general sampling methods and the different stages of drug development. It then focuses on simulation approaches based on game theory and the Markov decision process, simulations in classical and adaptive trials, and various challenges in clinical trial management and execution. The author goes on to cover 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. The final chapter explores Monte Carlo computing techniques for statistical inference.

This book offers a systematic treatment of computer simulation in drug development. It not only deals with the principles and methods of Monte Carlo simulation, but also the applications in drug development, such as statistical trial monitoring, prescription drug marketing, and molecular docking.

Reviews

"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

Table of Contents

Simulation, Simulation Everywhere

Modeling and Simulation

Introductory Monte Carlo Examples

Simulations in Drug Development

Virtual Sampling Techniques

Uniform Random Number Generation

General Sampling Methods

Efficiency Improvement in Virtual Sampling

Sampling Algorithms for Specific Distributions

Overview of Drug Development

Introduction

Drug Discovery

Preclinical Development

Clinical Development

Meta-Simulation for Pharmaceutical Industry

Introduction

Game Theory Basics

Pharmaceutical Games

Prescription Drug Global Pricing

Macro-Simulation for Pharmaceutical R & D

Sequential Decision-Making

Markov Decision Process

Pharmaceutical Decision Process

Extension of Markov Decision Process

Clinical Trial Simulation (CTS)

Classical Trial Simulation

Adaptive Trial Simulation

Clinical Trial Management and Execution

Introduction

Clinical Trial Management

Patient Recruitment and Projection

Randomization

Dynamic and Adaptive Drug Supply

Statistical Trial Monitoring

Prescription Drug Commercialization

Dynamics of Prescription Drug Marketing

Stock-Flow Dynamic Model for Brand Planning

Competitive Drug Marketing Strategy

Compulsory Licensing and Parallel Importation

Molecular Design and Simulation

Why Molecular Design and Simulation

Molecular Similarity Search

Overview of Molecular Docking

Small Molecule Confirmation Analysis

Ligand-Receptor Interaction

Docking Algorithms

Scoring Functions

Disease Modeling and Biological Pathway Simulation

Computational System Biology

Petri Nets

Biological Pathway Simulation

Pharmacokinetic Simulation

Overview of ADME

Absorption Modeling

Distribution

Metabolism Modeling

Excretion Modeling

Physiologically Based PK Model

Pharmacodynamic Simulation

Way to Pharmacodynamics

Enzyme Kinetics

Pharmacodynamic Models

Drug-Drug Interaction

Application of Pharmacodynamic Modeling

Monte Carlo for Inference and Beyond

Sorting Algorithm

Resampling Methods

Genetic Programming

Appendix A: JavaScript Programs

Appendix B: K-Stage Adaptive Design Stopping Boundaries

Afterword

Bibliography

A Summary and Exercises appear at the end of each chapter.

About the Author

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.

About the Series

Chapman & Hall/CRC Biostatistics Series

Learn more…

Subject Categories

BISAC Subject Codes/Headings:
MAT029000
MATHEMATICS / Probability & Statistics / General
MED071000
MEDICAL / Pharmacology
REF000000
REFERENCE / General