Biomedical Science


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Data and Safety Monitoring Committees in Clinical Trials, Second Edition

Jay Herson
December 13, 2016

Praise for the first edition: "Given the author’s years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book—not only for experts because of its cogent and organized presentation, but more importantly for young...

Analyzing Longitudinal Clinical Trial Data: A Practical Guide

Craig Mallinckrodt, Ilya Lipkovich
December 06, 2016

Analyzing Longitudinal Clinical Trial Data: A Practical Guide provides practical and easy to implement approaches for bringing the latest theory on analysis of longitudinal clinical trial data into routine practice.The book, with its example-oriented approach that includes numerous SAS and R code...

Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing

Harry Yang
December 01, 2016

The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-of-the-art book provides a single source of information on emerging statistical approaches to QbD and...

Concise Encyclopedia of Biostatistics for Medical Professionals

Abhaya Indrayan, Martin P. Holt
November 17, 2016

Concise Encyclopedia of Biostatistics for Medical Professionals focuses on conceptual knowledge and practical advice rather than mathematical details, enhancing its usefulness as a reference for medical professionals. The book defines and describes nearly 1000 commonly and not so commonly used...

Patient-Reported Outcomes: Measurement, Implementation and Interpretation

Joseph C. Cappelleri, Kelly H. Zou, Andrew G. Bushmakin, Jose Ma. J. Alvir, Demissie Alemayehu, Tara Symonds
November 16, 2016

Advancing the development, validation, and use of patient-reported outcome (PRO) measures, Patient-Reported Outcomes: Measurement, Implementation and Interpretation helps readers develop and enrich their understanding of PRO methodology, particularly from a quantitative perspective. Designed for...

Clinical Trials in Oncology, Third Edition

Stephanie Green, Jacqueline Benedetti, Angela Smith, John Crowley
October 14, 2016

The third edition of the bestselling Clinical Trials in Oncology provides a concise, nontechnical, and thoroughly up-to-date review of methods and issues related to cancer clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the...

Adaptive Design Theory and Implementation Using SAS and R, Second Edition

Mark Chang
October 14, 2016

Get Up to Speed on Many Types of Adaptive Designs 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...

Essentials of a Successful Biostatistical Collaboration

Arul Earnest
September 19, 2016

The aim of this book is to equip biostatisticians and other quantitative scientists with the necessary skills, knowledge, and habits to collaborate effectively with clinicians in the healthcare field. The book provides valuable insight on where to look for information and material on sample size...

Joint Modeling of Longitudinal and Time-to-Event Data

Robert Elashoff, Gang li, Ning Li
August 24, 2016

Longitudinal studies often incur several problems that challenge standard statistical methods for data analysis. These problems include non-ignorable missing data in longitudinal measurements of one or more response variables, informative observation times of longitudinal data, and survival...

Statistical Methods for Healthcare Performance Monitoring

Alex Bottle, Paul Aylin
August 01, 2016

Healthcare is important to everyone, yet large variations in its quality have been well documented both between and within many countries. With demand and expenditure rising, it’s more crucial than ever to know how well the healthcare system and all its components – from staff member to regional...

Bayesian Designs for Phase I–II Clinical Trials

Ying Yuan, Hoang Q. Nguyen, Peter F. Thall
June 22, 2016

Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials. At the same time, if promising preclinical results do not translate into a real treatment advance, it is important to...

Statistical Testing Strategies in the Health Sciences

Albert Vexler, Alan D. Hutson, Xiwei Chen
May 25, 2016

Statistical Testing Strategies in the Health Sciences provides a compendium of statistical approaches for decision making, ranging from graphical methods and classical procedures through computationally intensive bootstrap strategies to advanced empirical likelihood techniques. It bridges the gap...