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 Vivek Pradhan, Ashis Gangopadhyay, Sandeep M. Menon, Cynthia Basu, Tathagata Banerjee
January 29, 2024
Confidence Intervals for Discrete Data in Clinical Research is designed as a toolbox for biomedical researchers. Analysis of discrete data is one of the most used yet vexing areas in clinical research. The array of methodologies available in the literature to address the inferential questions for ...
Edited
By William Wang, Melvin Munsaka, James Buchanan, Judy Li
January 29, 2024
Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation provides a comprehensive coverage on safety monitoring methodologies, covering both global trends and regional initiatives. Pharmacovigilance has traditionally focused on the handling of individual ...
Edited
By Gang Li, Bruce Binkowitz, William Wang, Hui Quan, Josh Chen
January 29, 2024
Global simultaneous development is becoming more necessary as the cost of developing medical products continues to grow. The strategy of using multiregional clinical trials (MRCTs) has become the preferred method for developing new medicines. Implementing the same protocol to include subjects from ...
Edited
By Kristine Broglio, Binbing Yu
November 27, 2023
Drug development is a strictly regulated area. As such, marketing approval of a new drug depends heavily, if not exclusively, on evidence generated from clinical trials. Drug development has seen tremendous innovation in science and technology that has revolutionized the treatment of some diseases....
Edited
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 ...