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Clinical and Statistical Considerations in Personalized Medicine
Clinical and Statistical Considerations in Personalized Medicine explores recent advances related to biomarkers and their translation into clinical development. Leading clinicians, biostatisticians, regulators, commercial professionals, and researchers address the opportunities and challenges in successfully applying biomarkers in drug discovery and preclinical and clinical development. Robust Biomarkers for Drug Development and Disease Treatment The first four chapters discuss biomarker development from a clinical perspective. Coverage ranges from an introduction to biomarkers to advances in RNAi screens, epigenetics, and rare diseases as targets for personalized medicine approaches. Subseq...
Quantitative Evaluation of Safety in Drug Development
State-of-the-Art Methods for Drug Safety AssessmentResponding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product deve
Vaccine Development: From Concept to Clinic
Utilising successful case studies Vaccine Development will provide insight to the issues scientists face when producing a vaccine, the steps involved and will serve as an ideal reference tool regarding state-of-the-art vaccine development.
African Doctorates in Mathematics
This volume presents a catalogue of over 2000 doctoral theses by Africans in all fields of mathematics, including applied mathematics, mathematics education and history of mathematics. The introduction contains information about distribution by country, institutions, period, and by gender, about mathematical density, and mobility of mathematicians. Several appendices are included (female doctorate holders, doctorates in mathematics education, doctorates awarded by African universities to non-Africans, doctoral theses by non-Africans about mathematics in Africa, activities of African mathematicians at the service of their communities). Paulus Gerdes compiled the information in his capacity of Chairman of the African Mathematical Union Commission for the History of Mathematics in Africa (AMUCHMA). The book contains a preface by Mohamed Hassan, President of the African Academy of Sciences (AAS) and Executive Director of the Academy of Sciences for the Developing World (TWAS). (383 pp.)
Inference Principles for Biostatisticians
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 methodologies in the field. Drawing on his extensive experience teaching graduate-level biostatistics courses and working in the pharmaceutical industry, the author explains the main principles of statistical inference with many examples and exercises. Extended examples illustrate key concepts in depth using a specific biostatistical context. In addition, the author uses simulation to reinforce the repeated sampling interpretation of numerous statistical concepts. Reducing the computational complexities, he provides simple R functions for conducting simulation studies. This text gives graduate students with diverse backgrounds across the health, medical, social, and mathematical sciences a solid, unified foundation in the principles of statistical inference. This groundwork will lead students to develop a thorough understanding of biostatistical methodology.
Noninferiority Testing in Clinical Trials
Take Your NI Trial to the Next Level Reflecting the vast research on noninferiority (NI) designs from the past 15 years, Noninferiority Testing in Clinical Trials: Issues and Challenges explains how to choose the NI margin as a small fraction of the therapeutic effect of the active control in a clinical trial. Requiring no prior knowledge of NI testing, the book is easily accessible to both statisticians and nonstatisticians involved in drug development. With over 20 years of experience in this area, the author introduces the basic elements of the NI trials one at a time in a logical order. He discusses issues with estimating the effect size based on historical placebo control trials of the active control. The book covers fundamental concepts related to NI trials, such as assay sensitivity, constancy assumption, discounting, and preservation. It also describes patient populations, three-arm trials, and the equivalence of three or more groups.
Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials
Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials is the first book focused on the application of generalized linear mixed models and its related models in the statistical design and analysis of repeated measures from randomized controlled trials. The author introduces a new repeated measures design called S:T design combined with mixed models as a practical and useful framework of parallel group RCT design because of easy handling of missing data and sample size reduction. The book emphasizes practical, rather than theoretical, aspects of statistical analyses and the interpretation of results. It includes chapters in which the author describes some old-fashioned analysis designs that have been in the literature and compares the results with those obtained from the corresponding mixed models. The book will be of interest to biostatisticians, researchers, and graduate students in the medical and health sciences who are involved in clinical trials. Author Website:Data sets and programs used in the book are available at http://www.medstat.jp/downloadrepeatedcrc.html
Medical Product Safety Evaluation
Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in t...
Mixed Effects Models for the Population Approach
Wide-Ranging Coverage of Parametric Modeling in Linear and Nonlinear Mixed Effects Models Mixed Effects Models for the Population Approach: Models, Tasks, Methods and Tools presents a rigorous framework for describing, implementing, and using mixed effects models. With these models, readers can perform parameter estimation and modeling across a whole population of individuals at the same time. Easy-to-Use Techniques and Tools for Real-World Data Modeling The book first shows how the framework allows model representation for different data types, including continuous, categorical, count, and time-to-event data. This leads to the use of generic methods, such as the stochastic approximation of ...
Computing Science and Statistics
Interface '90 is the continuation of an ext!remely successful symposium series. The series has provided a forum for the interaction of professionals in statistics, computing science, and in numerical methods, wherein they may discuss a wide range of topics at the interface of these disciplines. This, the 22nd Symposium on the Interface: Computing Science and Statistics, was held 16-19 May, 1990 at the Kellogg Center on the campus of Michigan State University and is the third Symposium to be held under the recently organized Interface Foundation of North America. The Interface Board of Directors consists of the nine most recent Symposium Chairs: James E. Gentle, Lynne Billard, David M. Allen,...
