Biomedical Science


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Statistical Methods for Immunogenicity Assessment

Harry Yang, Jianchun Zhang, Binbing Yu, Wei Zhao
September 03, 2015

Develop Effective Immunogenicity Risk Mitigation Strategies Immunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation. Using advanced statistical methods in the study design and analysis stages is therefore essential...

Statistical Design and Analysis of Clinical Trials: Principles and Methods

Weichung Joe Shih, Joseph Aisner
July 23, 2015

Statistical Design and Analysis of Clinical Trials: Principles and Methods concentrates on the biostatistics component of clinical trials. Developed from the authors’ courses taught to public health and medical students, residents, and fellows during the past 15 years, the text shows how...

Statistical Methods for Drug Safety

Robert D. Gibbons, Anup Amatya
July 21, 2015

Explore Important Tools for High-Quality Work in Pharmaceutical Safety Statistical Methods for Drug Safety presents a wide variety of statistical approaches for analyzing pharmacoepidemiologic data. It covers both commonly used techniques, such as proportional reporting ratios for the analysis of...

Modern Adaptive Randomized Clinical Trials: Statistical and Practical Aspects

Oleksandr Sverdlov
June 30, 2015

Is adaptive randomization always better than traditional fixed-schedule randomization? Which procedures should be used and under which circumstances? What special considerations are required for adaptive randomized trials? What kind of statistical inference should be used to achieve valid and...

Empirical Likelihood Method in Survival Analysis

Mai Zhou
June 18, 2015

Add the Empirical Likelihood to Your Nonparametric Toolbox Empirical Likelihood Method in Survival Analysis explains how to use the empirical likelihood method for right censored survival data. The author uses R for calculating empirical likelihood and includes many worked out examples with the...

Introductory Adaptive Trial Designs: A Practical Guide with R

Mark Chang
June 08, 2015

All the Essentials to Start Using Adaptive Designs in No Time Compared to traditional clinical trial designs, adaptive designs often lead to increased success rates in drug development at reduced costs and time. Introductory Adaptive Trial Designs: A Practical Guide with R motivates newcomers to...

Health Technology Assessment: Using Biostatistics to Break the Barriers of Adopting New Medicines

Robert B. Hopkins, MA, MBA, PhD, Ron Goeree, MA
April 10, 2015

The term health technology refers to drugs, devices, and programs that can improve and extend quality of life. As decision-makers struggle to find ways to reduce costs while improving health care delivery, health technology assessments (HTA) provide the evidence required to make better-informed...

Introductory Statistics for the Health Sciences

Lise DeShea, Larry E. Toothaker
March 23, 2015

Introductory Statistics for the Health Sciences takes students on a journey to a wilderness where science explores the unknown, providing students with a strong, practical foundation in statistics. Using a color format throughout, the book contains engaging figures that illustrate real data sets...

Design and Analysis of Clinical Trials for Predictive Medicine

Shigeyuki Matsui, Marc Buyse, Richard Simon
March 19, 2015

Design and Analysis of Clinical Trials for Predictive Medicine provides statistical guidance on conducting clinical trials for predictive medicine. It covers statistical topics relevant to the main clinical research phases for developing molecular diagnostics and therapeutics—from identifying...

Inference Principles for Biostatisticians

Ian C. Marschner
December 11, 2014

Designed for students training to become biostatisticians as well as practicing biostatisticians, Inference Principles for Biostatisticians presents the theoretical and conceptual foundations of biostatistics. It covers the theoretical underpinnings essential to understanding subsequent core...

Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research

Chul Ahn, Moonseoung Heo, Song Zhang
December 09, 2014

Accurate sample size calculation ensures that clinical studies have adequate power to detect clinically meaningful effects. This results in the efficient use of resources and avoids exposing a disproportionate number of patients to experimental treatments caused by an overpowered study. Sample...

Modelling Survival Data in Medical Research, Third Edition

David Collett
December 04, 2014

Modelling Survival Data in Medical Research describes the modelling approach to the analysis of survival data using a wide range of examples from biomedical research. Well known for its nontechnical style, this third edition contains new chapters on frailty models and their applications, competing...