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 Sang Joon Lee, Shein-Chung Chow
September 25, 2023
Methodologies for Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product. These practical and challenging issues include, but are not limited to the mix-up use of interval...
By Jianrong Wu
July 24, 2023
Single-Arm Phase II Survival Trial Design provides a comprehensive summary to the most commonly- used methods for single-arm phase II trial design with time-to-event endpoints. Single-arm phase II trials are a key component for successfully developing advanced cancer drugs and treatments, ...
By J. Sunil Rao
July 11, 2023
A health disparity refers to a higher burden of illness, injury, disability, or mortality experienced by one group relative to others attributable to multiple factors including socioeconomic status, environmental factors, insufficient access to health care, individual risk factors, and behaviors ...
By Ram Tiwari, Jyoti Zalkikar, Lan Huang
June 26, 2023
Signal Detection for Medical Scientists: Likelihood Ratio Based Test-Based Methodology presents the data mining techniques with focus on likelihood ratio test (LRT) based methods for signal detection. It emphasizes computational aspect of LRT methodology and is pertinent for first-time researchers ...
By Marie Reilly
May 26, 2023
This book covers classic epidemiological designs that use a reference/control group, including case-control, case-cohort, nested case-control and variations of these designs, such as stratified and two-stage designs. It presents a unified view of these sampling designs as representations of an ...
By Christos Nakas, Leonidas Bantis, Constantine Gatsonis
May 26, 2023
This book presents a unified and up-to-date introduction to ROC methodologies, covering both diagnosis (classification) and prediction. The emphasis is on the conceptual underpinning of ROC analysis and the practical implementation in diverse scientific fields. A plethora of examples accompany the ...
By Song Zhang, Chul Ahn, Hong Zhu
May 16, 2023
This book begins with an introduction of pragmatic cluster randomized trials (PCTs) and reviews various pragmatic issues that need to be addressed by statisticians at the design stage. It discusses the advantages and disadvantages of each type of PCT, and provides sample size formulas, sensitivity ...
By Jeffrey Wilson, Ding-Geng Chen, Karl E. Peace
March 28, 2023
This book aims to compile typical fundamental-to-advanced statistical methods to be used for health data sciences. Although the book promotes applications to health and health-related data, the models in the book can be used to analyze any kind of data. The data are analyzed with the commonly used ...
By Bo Yang, Yang Song, Yijie Zhou
February 13, 2023
A disease is defined as rare if the prevalence is fewer than 200,000 in the United States. It is estimated that there are more than 7,000 rare diseases, which collectively affect 30 million Americans or 10% of the US population. This diverse and complex disease area poses challenges for patients, ...
By Rongling Wu
December 26, 2022
Modern medicine is undergoing a paradigm shift from a "one-size-fits-all" strategy to a more precise patient-customized therapy and medication plan. While the success of precision medicine relies on the level of pharmacogenomic knowledge, dissecting the genetic mechanisms of drug response in a ...
By Paul Faya, Tony Pourmohamad
December 15, 2022
The subject of this book is applied Bayesian methods for chemistry, manufacturing, and control (CMC) studies in the biopharmaceutical industry. The book has multiple authors from industry and academia, each contributing a case study (chapter). The collection of case studies covers a broad array of ...
By Oleksandr Sverdlov, Joris van Dam
December 06, 2022
One of the hallmarks of the 21st century medicine is the emergence of digital therapeutics (DTx)—evidence-based, clinically validated digital technologies to prevent, diagnose, treat, and manage various diseases and medical conditions. DTx solutions have been gaining interest from patients, ...