The primary objectives of the series are to provide useful reference books for researchers and scientists in academia, industry, and government, and also to offer textbooks for undergraduate and graduate courses in the areas of biostatistics and bioinformatics. The book series will provide comprehensive and unified presentations of statistical designs and analyses of important applications in biostatistics and bioinformatics, such as those in biological and biomedical research.
The scope of the series is wide, including applications of statistical methodology in biology, epidemiology, genetics, pharmaceutical science and clinical trials, public health, and medicine. The series is committed to providing easy to understand, state-of-the-art references and textbooks. In each volume, statistical concepts and methodologies will be illustrated through real world examples whenever possible.
Please contact us if you have an idea for a book for the series.
By Ying Kuen Cheung
March 29, 2011
As clinicians begin to realize the important role of dose-finding in the drug development process, there is an increasing openness to "novel" methods proposed in the past two decades. In particular, the Continual Reassessment Method (CRM) and its variations have drawn much attention in the medical ...
By Mohamed M. Shoukri
December 14, 2010
Measures of Interobserver Agreement and Reliability, Second Edition covers important issues related to the design and analysis of reliability and agreement studies. It examines factors affecting the degree of measurement errors in reliability generalization studies and characteristics influencing ...
By Andreas Wienke
July 26, 2010
The concept of frailty offers a convenient way to introduce unobserved heterogeneity and associations into models for survival data. In its simplest form, frailty is an unobserved random proportionality factor that modifies the hazard function of an individual or a group of related individuals. ...
By Karl E. Peace, Ding-Geng (Din) Chen
July 20, 2010
Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide a valid inference about the objective of the trial. Drawing from the authors’ courses on the subject ...
By Scott M. Berry, Bradley P. Carlin, J. Jack Lee, Peter Muller
July 19, 2010
Already popular in the analysis of medical device trials, adaptive Bayesian designs are increasingly being used in drug development for a wide variety of diseases and conditions, from Alzheimer’s disease and multiple sclerosis to obesity, diabetes, hepatitis C, and HIV. Written by leading pioneers ...
Edited
By Alex Dmitrienko, Ajit C. Tamhane, Frank Bretz
December 08, 2009
Useful Statistical Approaches for Addressing Multiplicity IssuesIncludes practical examples from recent trials Bringing together leading statisticians, scientists, and clinicians from the pharmaceutical industry, academia, and regulatory agencies, Multiple Testing Problems in Pharmaceutical ...
By Lyle D. Broemeling
January 12, 2009
Using WinBUGS to implement Bayesian inferences of estimation and testing hypotheses, Bayesian Methods for Measures of Agreement presents useful methods for the design and analysis of agreement studies. It focuses on agreement among the various players in the diagnostic process. The author employs ...
By Shein-Chung Chow, Jen-pei Liu
October 15, 2008
Preeminent Experts Update a Well-Respected Book 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 ...
By Shein-Chung Chow
May 30, 2007
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 ...
By Daryl S. Paulson
December 19, 2006
Carefully designed for use by clinical and pharmaceutical researchers and scientists, Handbook of Regression Analysis and Modeling explores statistical methods that have been adapted into biological applications for the quickly evolving field of biostatistics. The author clearly delineates a ...
By Christopher Jennison, Bruce W. Turnbull
September 15, 1999
Group sequential methods answer the needs of clinical trial monitoring committees who must assess the data available at an interim analysis. These interim results may provide grounds for terminating the study-effectively reducing costs-or may benefit the general patient population by allowing early...