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.
Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation
Simultaneous Global New Drug Development Multi-Regional Clinical Trials after ICH E17
Statistical Design, Monitoring, and Analysis of Clinical Trials Principles and Methods
Single-Arm Phase II Survival Trial Design
Applied Meta-Analysis with R and Stata
Advanced Survival Models
Edited By William Wang, Melvin Munsaka, James Buchanan, Judy Li
January 25, 2022
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
December 15, 2021
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 ...
By Michael A. Proschan
November 24, 2021
Statistical Thinking in Clinical Trials combines a relatively small number of key statistical principles and several instructive clinical trials to gently guide the reader through the statistical thinking needed in clinical trials. Randomization is the cornerstone of clinical trials and ...
By Vivek Pradhan, Ashis Gangopadhyay, Sandeep M. Menon, Cynthia Basu, Tathagata Banerjee
November 15, 2021
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 ...
By Weichung Joe Shih, Joseph Aisner
October 26, 2021
Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition concentrates on the biostatistics component of clinical trials. This new edition is updated throughout and includes five new chapters. Developed from the authors’ courses taught to public health and medical students, ...
Edited By Sang Joon Lee, Shein-Chung Chow
September 24, 2021
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 20, 2021
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 Ram Tiwari, Jyoti Zalkikar, Lan Huang
June 25, 2021
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 Ding-Geng (Din) Chen, Karl E. Peace
March 31, 2021
Review of the First Edition: The authors strive to reduce theory to a minimum, which makes it a self-learning text that is comprehensible for biologists, physicians, etc. who lack an advanced mathematics background. Unlike in many other textbooks, R is not introduced with meaningless toy examples; ...
By Douglas D. Gunzler, Adam T. Perzynski, Adam C. Carle
March 30, 2021
Structural equation modeling (SEM) is a very general and flexible multivariate technique that allows relationships among variables to be examined. The roots of SEM are in the social sciences. In writing this textbook, the authors look to make SEM accessible to a wider audience of researchers across...
By Catherine Legrand
March 23, 2021
Survival data analysis is a very broad field of statistics, encompassing a large variety of methods used in a wide range of applications, and in particular in medical research. During the last twenty years, several extensions of "classical" survival models have been developed to address particular ...
By Yingwei Peng, Binbing Yu
March 23, 2021
Cure Models: Methods, Applications and Implementation is the first book in the last 25 years that provides a comprehensive and systematic introduction to the basics of modern cure models, including estimation, inference, and software. This book is useful for statistical researchers and graduate ...