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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...

Classic biostatistics, a branch of statistical science, has as its main focus the applications of statistics in public health, the life sciences, and the pharmaceutical industry. Modern biostatistics, beyond just a simple application of statistics, is a confluence of statistics and knowledge of multiple intertwined fields. The application demands, the advancements in computer technology, and the rapid growth of life science data (e.g., genomics data) have promoted the formation of modern biostatistics. There are at least three characteristics of modern biostatistics: (1) in-depth...

Get Up to Speed on Many Types of Adaptive Designs

Since the publication of the first edition, there have been remarkable advances in the methodology and application of adaptive trials. Incorporating many of these new developments, Adaptive Design Theory and Implementation Using SAS and R, Second Edition offers a detailed framework to understand the use of various adaptive design methods in clinical trials.

New to the Second Edition

• Twelve new chapters covering blinded and semi-blinded sample size reestimation...

Paradoxes are poems of science and philosophy that collectively allow us to address broad multidisciplinary issues within a microcosm. A true paradox is a source of creativity and a concise expression that delivers a profound idea and provokes a wild and endless imagination. The study of paradoxes leads to ultimate clarity and, at the same time, indisputably challenges your mind.

Paradoxes in Scientific Inference analyzes paradoxes from many different perspectives: statistics, mathematics, philosophy, science, artificial intelligence, and more. The book elaborates...

Principles of Scientific Methods focuses on the fundamental principles behind scientific methods. The book refers to "science" in a broad sense, including natural science, physics, mathematics, statistics, social science, political science, and engineering science. A principle is often abstract and has broad applicability while a method is usually concrete and specific. The author uses many concrete examples to explain principles and presents analogies to connect different methods or problems to arrive at a general principle or a common notion. He mainly discusses a...

All the Essentials to Start Using Adaptive Designs in No Time

Compared to traditional clinical trial designs, adaptive designs often lead to increased success rates in drug development at reduced costs and time. Introductory Adaptive Trial Designs: A Practical Guide with R motivates newcomers to quickly and easily grasp the essence of adaptive designs as well as the foundations of adaptive design methods.

The book reduces the mathematics to a minimum and makes the material as practical as possible. Instead of providing general,...

Get Up to Speed on Many Types of Adaptive Designs

Since the publication of the first edition, there have been remarkable advances in the methodology and application of adaptive trials. Incorporating many of these new developments, Adaptive Design Theory and Implementation Using SAS and R, Second Edition offers a detailed framework to understand the use of various adaptive design methods in clinical trials.

New to the Second Edition

• Twelve new chapters covering blinded and semi-blinded sample size reestimation...

Classic biostatistics, a branch of statistical science, has as its main focus the applications of statistics in public health, the life sciences, and the pharmaceutical industry. Modern biostatistics, beyond just a simple application of statistics, is a confluence of statistics and knowledge of multiple intertwined fields. The application demands, the advancements in computer technology, and the rapid growth of life science data (e.g., genomics data) have promoted the formation of modern biostatistics. There are at least three characteristics of modern biostatistics: (1) in-depth...

With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA s recent draft guidance, a new edition of one of the first books on the topic is needed. Adaptive Design Methods in Clinical Trials, Second Edition reflects recent developments and regulatory positions on the use of adaptive designs in clinical trials. It unifies the vast and continuously growing literature and research activities on regulatory requirements, scientific and practical issues, and statistical methodology.

New to the Second...

The Future of Clinical Research and Health Care: From Empirical to Precision Medicine
Clinical and Statistical Considerations in Personalized Medicine explores recent advances related to biomarkers and their translation into clinical development. Leading clinicians, biostatisticians, regulators, commercial professionals, and researchers address the opportunities and challenges in successfully applying biomarkers in drug discovery and preclinical and clinical development.

Robust Biomarkers for Drug Development and Disease Treatment
The first...