Books in the Chapman & Hall/CRC Biostatistics Series series

Helping you become a skillful "simulator," this book provides broad coverage of the drug development process, from drug discovery to preclinical and clinical trial aspects to commercialization. It presents the theories and methods for carrying out computer simulations efficiently, covers both descriptive and pseudocode algorithms that provide the basis for implementing the simulation methods, and illustrates real-world problems through case studies. The author discusses many key topics, including game theory, adaptive design, molecular design, prescription drug marketing, biological pathway simulation, genetic programming, and pharmacokinetic modeling.

Showcasing a discussion of the experimental process and a review of basic statistics, this volume provides methodologies to identify general data distribution, skewness, and outliers. It features a unique classification of the nonparametric analogs of their parametric counterparts according to the strength of the collected data. Applied Statistical Designs for the Researcher discusses three varieties of the Student t test, including a comparison of two different groups with different variances; two groups with the same variance; and a matched, paired group. It introduces the analysis of variance and Latin Square designs and presents screening approaches to comparing two factors and their interactions.

This volume discusses the development and application of Bayesian statistical methods for the analysis of high-throughput bioinformatics data arising from problems in molecular and structural biology and disease-related medical research. It presents a broad overview of statistical inference, clustering, and classification problems in two main high-throughput platforms: microarray gene expression and phylogenic analysis. Illustrating concepts using real-world data, the book covers a variety of recently developed Bayesian techniques, along with applications in genome-wide studies, phylogenetics, breast cancer, expression genomics, and more.

Methodologies in Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product.

This book concentrates on the biostatistics component of clinical trials. This new, second edition is updated throughout and includes three new chapters. This text reflects the academic research, commercial development, and public health aspects of clinical trials.

Employs a Bayesian approach to provide statistical inferences based on various models of intra- and inter rater agreement. This book explores numerous measures of agreement, including the Kappa coefficient, the G coefficient, and intraclass correlation. It discusses how to successfully design and analyze an agreement study.

This book is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development.

Cluster Randomised Trials, Second Edition explores the advantages of cluster randomisation, with special attention given to evaluating the effects of interventions against infectious diseases. Avoiding unnecessary mathematical detail, it covers basic concepts underlying the use of cluster randomisation.

Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Issues and challenges in the design and analysis of safety studies are covered.

This book provides a broad perspective of new quantitative methods in HIV/AIDS research, contributed by those immersed in HIV research. It is the editors' hope that the work will inspire more statisticians, mathematicians and computer scientists to collaborate and contribute to the interdisciplinary challenges of addressing the AIDS pa

The aim of this book is to equip biostatisticians and other quantitative scientists with the necessary skills, knowledge, and habits to collaborate effectively with clinicians in the healthcare field. The book provides valuable insight on where to look for information and material on sample size and statistical techniques commonly used in clinic

This book explains how to determine sample size for studies with correlated outcomes, which are widely implemented in medical, epidemiological, and behavioral studies. For clustered studies, the authors provide sample size formulas that account for variable cluster sizes and within-cluster correlation. For longitudinal studies, they present samp

Written by a team of experienced leaders, this book brings the most advanced knowledge and statistical methods of drug safety to the statistical, clinical, and safety community. It explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product development. The book addr

This text gives graduate students with diverse backgrounds across the health, medical, social, and mathematical sciences a solid, unified foundation in the principles of statistical inference. Drawing on his extensive experience teaching graduate-level biostatistics courses and working in the pharmaceutical industry, the author covers the theore

Requiring no prior knowledge of NI testing, this book explains how to choose the NI margin as a small fraction of the therapeutic effect of the active control in a clinical trial. It discusses issues with estimating the effect size based on historical placebo control trials of the active control. The author covers basic concepts related to NI tr

Bringing together the expertise of 15 contributors from academia and the industry, this book offers an easy-to-read guide to the various facets of benefit-risk assessment in the major stages of pharmaceutical R&D, from early clinical development to late-stage development to regulatory review to post-launch assessment. Suitable for those in b

Designed for nonstatisticians and statisticians new to the analysis of growth and development data, this book is an accessible and practical guide to a wide range of basic and advanced statistical methods that are useful for studying human growth and development. It collects methods scattered throughout the literature and explains how to use the

Written by a biostatistics expert with over 20 years of experience in the field, this book is the first to introduce epidemiology from a Bayesian perspective. It shows epidemiologists how Bayesian models and techniques are useful in studying the association between disease and exposure to risk factors. With many examples and end-of-chapter exerc