A comprehensive and practical resource for analyses of crossover designs For ethical reasons, it is vital to keep the number of patients in a clinical trial as low as possible. As evidenced by extensive research publications, crossover design can be a useful and powerful tool to reduce the number of patients needed for a parallel group design in studying treatments for non-curable chronic diseases. This book introduces commonly-used and well-established statistical tests and estimators in epidemiology that can easily be applied to hypothesis testing and estimation of the relative treatment effect for various types of data scale in crossover designs. Models with distribution-free random effects are assumed and hence most approaches considered here are semi-parametric. The book provides clinicians and biostatisticians with the exact test procedures and exact interval estimators, which are applicable even when the number of patients in a crossover trial is small. Systematic discussion on sample size determination is also included, which will be a valuable resource for researchers involved in crossover trial design. Key features: Provides exact test procedures and interval estimators, which are especially of use in small-sample cases. Presents most test procedures and interval estimators in closed-forms, enabling readers to calculate them by use of a pocket calculator or commonly-used statistical packages. Each chapter is self-contained, allowing the book to be used a reference resource. Uses real-life examples to illustrate the practical use of test procedures and estimators Provides extensive exercises to help readers appreciate the underlying theory, learn other relevant test procedures and understand how to calculate the required sample size. Crossover Designs: Testing, Estimation and Sample Size will be a useful resource for researchers from biostatistics, as well as pharmaceutical and clinical sciences. It can also be used as a textbook or reference for graduate students studying clinical experiments.

This monograph presents a comprehensive and up-to-date account of the developments in optimality aspects of crossover designs. Crossover designs are immensely useful in various areas of human investigation including agriculture, animal nutrition, clinical trials, pharmaceutical studies, biological assays, weather modification experiments, sensory evaluation of food products and learning experiments. Research on the optimality aspects of crossover designs has developed only in the last three decades, and it has now emerged as a potential field for further investigation. This book is the first comprehensive treatise on this subject. It covers optimal crossover designs at length by consolidating vast amounts of material from the literature, and includes many recent and deep results. It is expected that this book will not only provide a one-stop reference for the available results, but also encourage further research in this area of substantial practical relevance.

The first edition of Design and Analysis of Cross-Over Trials quickly became the standard reference on the subject and has remained so for more than 12 years. In that time, however, the use of cross-over trials has grown rapidly, particularly in the pharmaceutical arena, and researchers have made a number of advances in both the theory and methods applicable to these trials. Completely revised and updated, the long-awaited second edition of this classic text retains its predecessor's careful balance of theory and practice while incorporating new approaches, more data sets, and a broader scope. Enhancements in the second edition include: A new chapter on bioequivalence Recently developed methods for analyzing longitudinal continuous and categorical data Real-world examples using the SAS system A comprehensive catalog of designs, datasets, and SAS programs available on a companion Web site at www.crcpress.com The authors' exposition gives a clear, unified account of the design and analysis of cross-over trials from a statistical perspective along with their methodological underpinnings. With SAS programs and a thorough treatment of design issues, Design and Analysis of Cross-Over Trials, Second Edition sets a new standard for texts in this area and undoubtedly will be of direct practical value for years to come.

Gives advice on how to design a clinical trial and compares the different designs.

The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government

This rewritten and updated second edition provides comprehensive information on the wide-ranging applications of statistics in the pharmacological field. Focusing on practical aspects, it sets out to bridge the gap between industry and academia.;Reflecting the changes that have taken place since publication of the first edition, this volume covers new topics such as: cancer clinical trials, clinical trials of AIDS patients and animal tumorigenicity studies; the development of antiepileptic drugs; the role of epidemiology in postmarketing trials and adverse drug experience; computer-assisted new drug application (CANDA) submissions; contract research organizations; interim analysis in clinical trials; and room-temperature tests for the stability of drugs.;This work is intended as: a reference for statisticians, biostatisticians, pharmacologists, administrators, managers, and scientists in the pharmaceutical industry; and a text for graduate students taking courses in applied statistics or pharmaceutical statistics.

Design and Analysis of Cross-Over Trials is concerned with a specific kind of comparative trial known as the cross-over trial, in which subjects receive different sequences of treatments. Such trials are widely used in clinical and medical research, and in other diverse areas such as veterinary science, psychology, sports science, and agriculture.T

A complete and well-balanced introduction to modern experimental design Using current research and discussion of the topic along with clear applications, Modern Experimental Design highlights the guiding role of statistical principles in experimental design construction. This text can serve as both an applied introduction as well as a concise review of the essential types of experimental designs and their applications. Topical coverage includes designs containing one or multiple factors, designs with at least one blocking factor, split-unit designs and their variations as well as supersaturated and Plackett-Burman designs. In addition, the text contains extensive treatment of: Conditional effects analysis as a proposed general method of analysis Multiresponse optimization Space-filling designs, including Latin hypercube and uniform designs Restricted regions of operability and debarred observations Analysis of Means (ANOM) used to analyze data from various types of designs The application of available software, including Design-Expert, JMP, and MINITAB This text provides thorough coverage of the topic while also introducing the reader to new approaches. Using a large number of references with detailed analyses of datasets, Modern Experimental Design works as a well-rounded learning tool for beginners as well as a valuable resource for practitioners.

Preeminent Experts Update a Well-Respected BookTaking 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 bioequiva

This carefully edited collection synthesizes the state of the art in the theory and applications of designed experiments and their analyses. It provides a detailed overview of the tools required for the optimal design of experiments and their analyses. The handbook covers many recent advances in the field, including designs for nonlinear models and algorithms applicable to a wide variety of design problems. It also explores the extensive use of experimental designs in marketing, the pharmaceutical industry, engineering and other areas.