Being that pharmacokinetics (PK) is the study of how the body handles various substances, it is not surprising that PK plays an important role in the early development of new drugs. However, the clinical research community widely believes that mathematics in some way blurs the true meaning of PK. Demonstrating that quite the opposite is true, Computational Pharmacokinetics outlines the fundamental concepts and models of PK from a mathematical perspective based on clinically relevant parameters. After an introductory chapter, the book presents a noncompartmental approach to PK and...
Being that pharmacokinetics (PK) is the study of how the body handles various substances, it is not surprising that PK plays an important role in the ...
< P> Bayesian analyses have made important inroads in modern clinical research due, in part, to the incorporation of the traditional tools of noninformative priors as well as the modern innovations of adaptive randomization and predictive power. Presenting an introductory perspective to modern Bayesian procedures, Elementary Bayesian Biostatistics explores Bayesian principles and illustrates their application to healthcare research. Building on the basics of classic biostatistics and algebra, this easy-to-read book provides a clear overview of the subject. It focuses on the history and...
< P> Bayesian analyses have made important inroads in modern clinical research due, in part, to the incorporation of the traditional tools of noninfor...
The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how stability studies play an important role in drug safety and quality assurance, Statistical Design and Analysis of Stability Studies presents the principles and methodologies in the design and analysis of stability studies. After introducing the...
The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability d...
Taking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition provides a complete presentation of the latest progress of activities and results in bioavailability and bioequivalence on regulatory requirements, scientific and practical issues, and statistical methodology.
New to the Third Edition
Four new chapters that present a thorough account...
Preeminent Experts Update a Well-Respected Book
Taking into account the regulatory and scientific developments that have occurred s...
In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice. But by identifying the causes of the issues and correcting them, the study objectives of clinical trials can be better achieved. Controversial Statistical Issues in Clinical Trials covers commonly encountered controversial statistical issues in clinical trials and, whenever possible, makes recommendations to resolve these problems.
The book focuses on issues occurring at various stages of...
In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good ...
Useful in many areas of medicine and biology, Bayesian methods are particularly attractive tools for the design of clinical trials and diagnostic tests, which are based on established information, usually from related previous studies. AdvancedBayesian Methods for Medical Test Accuracy begins with a review of the usual measures such as specificity, sensitivity, positive and negative predictive value, and the area under the ROC curve. Then the scope expands to cover the more advanced topics of verification bias, diagnostic tests with imperfect gold...
Useful in many areas of medicine and biology, Bayesian methods are particularly attractive tools for the design of clinical trials and diagnostic t...
As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed. To accelerate the product development process and shorten approval time, researchers are beginning to design multiregional trials that incorporate subjects from many countries around the world under the same protocol.
Design and Analysis of Bridging Studies addresses the issues arising from bridging studies and multiregional clinical trials. For bridging studies, the book explores ethnic sensitivity, the...
As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to...
Interval-Censored Time-to-Event Data: Methods and Applications collects the most recent techniques, models, and computational tools for interval-censored time-to-event data. Top biostatisticians from academia, biopharmaceutical industries, and government agencies discuss how these advances are impacting clinical trials and biomedical research.
Divided into three parts, the book begins with an overview of interval-censored data modeling, including nonparametric estimation, survival functions, regression analysis, multivariate data analysis, competing risks...
Interval-Censored Time-to-Event Data: Methods and Applications collects the most recent techniques, models, and computational tool...
Adaptive Designs for Sequential Treatment Allocation presents a rigorous theoretical treatment of the results and mathematical foundation of adaptive design theory. The book focuses on designing sequential randomized experiments to compare two or more treatments incorporating information accrued along the way.
The authors first introduce the terminology and statistical models most commonly used in comparative experiments. They then illustrate biased coin and urn designs that only take into account past treatment allocations as well as designs that use past...
Adaptive Designs for Sequential Treatment Allocation presents a rigorous theoretical treatment of the results and mathematical fou...
Health economics is concerned with the study of the cost-effectiveness of health care interventions. This book provides an overview of Bayesian methods for the analysis of health economic data. After an introduction to the basic economic concepts and methods of evaluation, it presents Bayesian statistics using accessible mathematics. The next chapters describe the theory and practice of cost-effectiveness analysis from a statistical viewpoint, and Bayesian computation, notably MCMC. The final chapter presents three detailed case studies covering cost-effectiveness analyses using individual...
Health economics is concerned with the study of the cost-effectiveness of health care interventions. This book provides an overview of Bayesian met...
