Biomedical Science

Biostatistics

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Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments

Qi Jiang, Weili He
May 24, 2016

Guides You on the Development and Implementation of B–R Evaluations Benefit–Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit–risk (B–R) frameworks...

Multiregional Clinical Trials for Simultaneous Global New Drug Development

Joshua Chen, Hui Quan
April 01, 2016

In a global clinical development strategy, multiregional clinical trials (MRCTs) are vital in the development of innovative medicines. Multiregional Clinical Trials for Simultaneous Global New Drug Development presents a comprehensive overview on the current status of conducting MRCTs in clinical...

Basic Statistics and Epidemiology: A Practical Guide, Fourth Edition

Antony Stewart
February 15, 2016

Basic Statistics and Epidemiology is a straightforward primer in basic statistics that emphasizes its practical use in epidemiology and public health, providing an understanding of essential topics such as study design, data analysis and statistical methods used in the execution of medical research...

Singular Spectrum Analysis of Biomedical Signals

Saeid Sanei, Hossein Hassani
December 22, 2015

Recent advancements in signal processing and computerised methods are expected to underpin the future progress of biomedical research and technology, particularly in measuring and assessing signals and images from the human body. This book focuses on singular spectrum analysis (SSA), an effective...

Dynamical Biostatistical Models

Daniel Commenges, Helene Jacqmin-Gadda
October 02, 2015

Dynamical Biostatistical Models presents statistical models and methods for the analysis of longitudinal data. The book focuses on models for analyzing repeated measures of quantitative and qualitative variables and events history, including survival and multistate models. Most of the advanced...

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...

Conferences

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