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Development of Gene Therapies
Cell and gene therapies have become the third major drug modality in pharmaceutical medicine of the 21st century after low molecular weight and antibody drugs. The gene therapy (GTx) field is rapidly advancing, and yet there are still fundamental scientific questions that remain to be answered. Development of GTx products poses unique challenges and opportunities for drug developers. However, there is lack of a systematic exposition of the GTx product development and the pivotal role of the biostatistician in this process. Development of Gene Therapies: Strategic, Scientific, and Regulatory, and Access Considerations attempts to summarize the current state-of-the-art strategic, scientific, s...
Power and Sample Size in R
Power and Sample Size in R guides the reader through power and sample size calculations for a wide variety of study outcomes and designs and illustrates their implementation in R software. It is designed to be used as a learning tool for students as well as a resource for experienced statisticians and investigators. The book begins by explaining the process of power calculation step by step at an introductory level and then builds to increasingly complex and varied topics. For each type of study design, the information needed to perform a calculation and the factors that affect power are explained. Concepts are explained with statistical rigor but made accessible through intuition and exampl...
Probability Modeling and Statistical Inference in Cancer Screening
Cancer screening has been carried out for six decades – however, there are many unsolved problems: how to estimate key parameters involved in screenings, such as sensitivity, the time duration in the preclinical state (i.e., sojourn time), and time duration in the disease-free state; how to estimate the distribution of lead time, the diagnosis time advanced by screening; how to evaluate the long-term outcomes of screening, including the probability of overdiagnosis among the screen-detected; when to schedule the first exam based on one’s current age and risk tolerance; and when to schedule the upcoming exam based on one’s screening history, age, and risk tolerance. These problems need ...
Biostatistics for Bioassay
In recent decades, there has been enormous growth in biologics research and development, with the accompanying development of biological assays for emerging products. In parallel, there have been substantial advances in statistical methodology, as well as technological advances in computer power, enabling new techniques to be implemented via statistical software. Biostatistics for Bioassay presents an overview of the statistical analysis techniques that are needed in order to report the results of biological assays. These assays are needed for testing all biological medicines, such as vaccines and cell therapies, to allow them to be released for use. Beginning with consideration of the perfo...
Likelihood Methods in Survival Analysis
Many conventional survival analysis methods, such as the Kaplan-Meier method for survival function estimation and the partial likelihood method for Cox model regression coefficients estimation, were developed under the assumption that survival times are subject to right censoring only. However, in practice, survival time observations may include interval-censored data, especially when the exact time of the event of interest cannot be observed. When interval-censored observations are present in a survival dataset, one generally needs to consider likelihood-based methods for inference. If the survival model under consideration is fully parametric, then likelihood-based methods impose neither t...
Cluster Randomization Trials
Oftentimes, small groups (called clusters) of individuals (called subunits) are randomized between treatment arms. Typically, clusters are families, classes, communities, surgeons operating patients, and so on. Such trials are called cluster randomization trials (CRTs). The subunits in each cluster share common frailties so that their outcomes tend to be positively correlated. Since clusters are independent, the data in two arms are independent in CRTs. In a clinical trial, multiple sites (such as teeth or ears) from each subject may be randomized between different treatment arms. In this case, the sites (subunits) of each subject (cluster) share common genetic, physiological, or environment...
Causal Inference in Pharmaceutical Statistics
Causal Inference in Pharmaceutical Statistics introduces the basic concepts and fundamental methods of causal inference relevant to pharmaceutical statistics. This book covers causal thinking for different types of commonly used study designs in the pharmaceutical industry, including but not limited to randomized controlled clinical trials, longitudinal studies, singlearm clinical trials with external controls, and real-world evidence studies. The book starts with the central questions in drug development and licensing, takes the reader through the basic concepts and methods via different study types and through different stages, and concludes with a roadmap to conduct causal inference in cl...
Statistical Methods for Dynamic Disease Screening and Spatio-Temporal Disease Surveillance
Disease screening and disease surveillance (DSDS) constitute two critical areas in public health, each presenting distinctive challenges primarily due to their sequential decision-making nature and complex data structures. Statistical Methods for Dynamic Disease Screening and Spatio-Temporal Disease Surveillance explores numerous recent analytic methodologies that enhance traditional techniques. The author, a prominent researcher specializing in innovative sequential decision-making techniques, demonstrates how these novel methods effectively address the challenges of DSDS. After a concise introduction that lays the groundwork for comprehending the challenges inherent in DSDS, the book delve...
Association Models in Epidemiology
Association Models in Epidemiology: Study Designs, Modeling Strategies, and Analytic Methods is written by an epidemiologist for graduate students, researchers, and practitioners who will use regression techniques to analyze data. It focuses on association models rather than prediction models. The book targets students and working professionals who lack bona fide modeling experts but are committed to conducting appropriate regression analyses and generating valid findings from their projects. This book aims to offer detailed strategies to guide them in modeling epidemiologic data. Features Custom-Tailored Models: Discover association models specifically designed for epidemiologic study desig...
Smart Cities: Power Electronics, Renewable Energy, and Internet of Things
This book discusses the integration of power electronics, renewable energy, and the Internet of Things (IoT) from the perspective of smart cities in a single volume. The text will be helpful for senior undergraduate, graduate students and academic researchers in diverse engineering fields including electrical, electronics and communication, and computers. The book: Covers the integration of power electronics, energy harvesting, and the IoT for smart city applications Discusses concepts of power electronics and the IoT in electric vehicles for smart cities Examines the integration of power electronics in renewable energy for smart cities Discusses important concepts of energy harvesting inclu...
