Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrates the methods using real world examples.

Now in a fully revised Fourth Edition, Modern Epidemiology remains the gold standard text in this complex and evolving field. This edition continues to provide comprehensive coverage of the principles and methods for the design, analysis, and interpretation of epidemiologic research. Featuring a new format allowing space for margin notes, this edition • Reflects both the conceptual development of this evolving science and the increasing role that epidemiology plays in improving public heal...

In the past thirty years epidemiology has matured from a fledgling scientific field into a vibrant discipline that brings together the biological and social sciences, and in doing so draws upon disciplines ranging from statistics and survey sampling to the philosophy of science. These areas of knowledge have converged into a modern theory of epidemiology that has been slow to penetrate into textbooks, particularly at the introductory level. Epidemiology: An Introduction closes the...

This volume, representing a compilation of authoritative reviews on a multitude of uses of statistics in epidemiology and medical statistics written by internationally renowned experts, is addressed to statisticians working in biomedical and epidemiological fields who use statistical and quantitative methods in their work. While the use of statistics in these fields has a long and rich history, explosive growth of science in general and clinical and epidemiological sciences in particular h...

Praise for the Second Edition:"… this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics"This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehens...

A new edition of the classic guide to the use of statistics in medicine, featuring examples from articles in the New England Journal of MedicineMedical Uses of Statistics has served as one of the most influential works on the subject for physicians, physicians-in-training, and a myriad of healthcare experts who need a clear idea of the proper application of statistical techniques in clinical studies as well as the implications of their interpretat...

A practical guide to network meta-analysis with examples and codeIn the evaluation of healthcare, rigorous methods of quantitative assessment are necessary to establish which interventions are effective and cost-effective. Often a single study will not provide the answers and it is desirable to synthesise evidence from multiple sources, usually randomised controlled trials. This book takes an approach to evidence synthesis that is specifically intended for decision...

Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field.Written specifically for pharmaceutical practition...

The book aims to provide both comprehensive reviews of the classical methods and an introduction to new developments in medical statistics. The topics range from meta analysis, clinical trial design, causal inference, personalized medicine to machine learning and next generation sequence analysis. Since the publication of the first edition, there have been tremendous advances in biostatistics and bioinformatics. The new edition tries to cover as many important emerging areas and reflect as...

Providing genome-informed personalized treatment is a goal of modern medicine. Identifying new translational targets in nucleic acid characterizations is an important step toward that goal. The information tsunami produced by such genome-scale investigations is stimulating parallel developments in statistical methodology and inference, analytical frameworks, and computational tools. Within the context of genomic medicine and with a strong focus on cancer research, this book describes the i...

Praise for the Second Edition:“...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite.” —Journal of Clinical Research Best PracticesThe Third Edition of Design and Analysis of Clinical Trials provides complete, comprehensive, and expanded coverage of recent health treatments and interventions. Featuring a unified presentation, the book provides...

The field of statistics not only affects all areas of scientific activity, but also many other matters such as public policy. It is branching rapidly into so many different subjects that a series of handbooks is the only way of comprehensively presenting the various aspects of statistical methodology, applications, and recent developments. The Handbook of Statistics, a series of self-contained reference books. Each volume is devoted to a particular topic in statistics with Volume 28 dealin...