State-of-the-Art Methods for Drug Safety Assessment
Responding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product development. It presents the latest statistical methods for drug safety assessment.
The book s three sections focus on study design, safety monitoring, and data evaluation/analysis. The book...
State-of-the-Art Methods for Drug Safety Assessment
Responding to the increased scrutiny of drug safety in recent years,
Designed for students training to become biostatisticians as well as practicing biostatisticians, Inference Principles for Biostatisticians presents the theoretical and conceptual foundations of biostatistics. It covers the theoretical underpinnings essential to understanding subsequent core methodologies in the field.
Drawing on his extensive experience teaching graduate-level biostatistics courses and working in the pharmaceutical industry, the author explains the main principles of statistical inference with many examples and exercises. Extended examples...
Designed for students training to become biostatisticians as well as practicing biostatisticians, Inference Principles for Biostatisticians...
Wide-Ranging Coverage of Parametric Modeling in Linear and Nonlinear Mixed Effects Models Mixed Effects Models for the Population Approach: Models, Tasks, Methods and Tools presents a rigorous framework for describing, implementing, and using mixed effects models. With these models, readers can perform parameter estimation and modeling across a whole population of individuals at the same time.
Easy-to-Use Techniques and Tools for Real-World Data Modeling The book first shows how the framework allows model representation for different data types, including continuous, categorical,...
Wide-Ranging Coverage of Parametric Modeling in Linear and Nonlinear Mixed Effects Models Mixed Effects Models for the Population Approach: Mode...
Accurate sample size calculation ensures that clinical studies have adequate power to detect clinically meaningful effects. This results in the efficient use of resources and avoids exposing a disproportionate number of patients to experimental treatments caused by an overpowered study.
Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research explains how to determine sample size for studies with correlated outcomes, which are widely implemented in medical, epidemiological, and behavioral studies.
The book focuses on issues specific to the two types of...
Accurate sample size calculation ensures that clinical studies have adequate power to detect clinically meaningful effects. This results in the eff...
Reflecting the vast research on noninferiority (NI) designs from the past 15 years, Noninferiority Testing in Clinical Trials: Issues and Challenges explains how to choose the NI margin as a small fraction of the therapeutic effect of the active control in a clinical trial. Requiring no prior knowledge of NI testing, the book is easily accessible to both statisticians and nonstatisticians involved in drug development.
With over 20 years of experience in this area, the author introduces the basic...
Take Your NI Trial to the Next Level
Reflecting the vast research on noninferiority (NI) designs from the past 15 years,
Economic evaluation has become an essential component of clinical trial design to show that new treatments and technologies offer value to payers in various healthcare systems. Although many books exist that address the theoretical or practical aspects of cost-effectiveness analysis, this book differentiates itself from the competition by detailing how to apply health economic evaluation techniques in a clinical trial context, from both academic and pharmaceutical/commercial perspectives. It also includes a special chapter for clinical trials in Cancer. Design & Analysis of Clinical...
Economic evaluation has become an essential component of clinical trial design to show that new treatments and technologies offer value to payers i...
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...
Get Up to Speed on Many Types of Adaptive Designs
Since the publication of the first edition, there have been remarkable ad...
The growing interest in using combination drugs to treat various complex diseases has spawned the development of many novel statistical methodologies. The theoretical development, coupled with advances in statistical computing, makes it possible to apply these emerging statistical methods in in vitro and in vivo drug combination assessments. However, despite these advances, no book has served as a single source of information for statistical methods in drug combination research, nor has there been any guidance for experimental strategies.
Statistical Methods in Drug...
The growing interest in using combination drugs to treat various complex diseases has spawned the development of many novel statistical methodologi...
Design and Analysis of Clinical Trials for Predictive Medicine provides statistical guidance on conducting clinical trials for predictive medicine. It covers statistical topics relevant to the main clinical research phases for developing molecular diagnostics and therapeutics from identifying molecular biomarkers using DNA microarrays to confirming their clinical utility in randomized clinical trials.
The foundation of modern clinical trials was laid many years before modern developments in biotechnology and genomics. Drug development in many diseases is now shifting to molecularly...
Design and Analysis of Clinical Trials for Predictive Medicine provides statistical guidance on conducting clinical trials for predictive medicine....
Effectively Assess Intervention Options for Controlling Infectious Diseases
Our experiences with the human immunodeficiency virus (HIV), severe acute respiratory syndrome (SARS), and Ebola virus disease (EVD) remind us of the continuing need to be vigilant against the emergence of new infectious diseases. Mathematical modeling is increasingly used in the management of infectious disease control as a way to assess interventions relatively quickly, cheaply, and safely. Modeling to Inform Infectious Disease Control shows readers how to take advantage...
Effectively Assess Intervention Options for Controlling Infectious Diseases
Our experiences with the human immunodeficiency...
