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    A Manager's Guide to the Design and Conduct of Clinical Trials

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    This newly updated edition of the benchmark guide to computer-assisted clinical trials provides a comprehensive primer for prospective managers. It covers every critical issue of the design and conduct of clinical trials, including study design, organization, regulatory agency liaison, data collection and analysis, as well as recruitment, software, monitoring, and reporting. Keeping the same user-friendly format as the original, this Second Edition features new examples and the latest developments in regulatory guidelines, such as e-submission procedures and computerized direct data acquisition. The new edition also reflects the increasing globalization of clinical trial activities, and includes new information about international standards and procedures, including the Common Technical Document and CDISC standards. This step-by-step guide is supported by handy checklists and extracts from submitted protocols. Experienced author and consultant Phillip Good incorporateshumorous yet instructive anecdotes to illustrate common pitfalls. Based on the proven industrial formula of planning, implementing, and finally performing essential checks, the book's three sections-"Plan," «Do,» and «Check»-includethe following material: * Should the trials be conducted? * Put it in the computer and keep it there * Staffing for success * Designing trials and determining sample size * Budgeting * Recruiting and retaining patients and physicians * Data management * Monitoring the trials * Data analysis * After action review * Exception handling Executive and managerial professionals involved in the design and analysis of clinical experiments, along with clinical research associates, biostatisticians, and students in public health will find A Manager's Guide an indispensable resource. Praise for the First Edition: «. . . readable, informative and at times witty . . . never stops being concise and well written . . . a book worth a read . . .» -Statistics in Medicine «The book is very prescriptive and full of lists and tables with which to guide managers in making effective decisions in using computer-assisted clinical trials in pharmaceutical studies.» -Technometrics «This book is must-have reading for anyone in the business . . .» -Clinical Chemistry

    Contemporary Bayesian Econometrics and Statistics

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    Tools to improve decision making in an imperfect world This publication provides readers with a thorough understanding of Bayesian analysis that is grounded in the theory of inference and optimal decision making. Contemporary Bayesian Econometrics and Statistics provides readers with state-of-the-art simulation methods and models that are used to solve complex real-world problems. Armed with a strong foundation in both theory and practical problem-solving tools, readers discover how to optimize decision making when faced with problems that involve limited or imperfect data. The book begins by examining the theoretical and mathematical foundations of Bayesian statistics to help readers understand how and why it is used in problem solving. The author then describes how modern simulation methods make Bayesian approaches practical using widely available mathematical applications software. In addition, the author details how models can be applied to specific problems, including: * Linear models and policy choices * Modeling with latent variables and missing data * Time series models and prediction * Comparison and evaluation of models The publication has been developed and fine- tuned through a decade of classroom experience, and readers will find the author's approach very engaging and accessible. There are nearly 200 examples and exercises to help readers see how effective use of Bayesian statistics enables them to make optimal decisions. MATLAB? and R computer programs are integrated throughout the book. An accompanying Web site provides readers with computer code for many examples and datasets. This publication is tailored for research professionals who use econometrics and similar statistical methods in their work. With its emphasis on practical problem solving and extensive use of examples and exercises, this is also an excellent textbook for graduate-level students in a broad range of fields, including economics, statistics, the social sciences, business, and public policy.

    Probability, Statistics, and Stochastic Processes

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    A mathematical and intuitive approach to probability, statistics, and stochastic processes This textbook provides a unique, balanced approach to probability, statistics, and stochastic processes. Readers gain a solid foundation in all three fields that serves as a stepping stone to more advanced investigations into each area. This text combines a rigorous, calculus-based development of theory with a more intuitive approach that appeals to readers' sense of reason and logic, an approach developed through the author's many years of classroom experience. The text begins with three chapters that develop probability theory and introduce the axioms of probability, random variables, and joint distributions. The next two chapters introduce limit theorems and simulation. Also included is a chapter on statistical inference with a section on Bayesian statistics, which is an important, though often neglected, topic for undergraduate-level texts. Markov chains in discrete and continuous time are also discussed within the book. More than 400 examples are interspersed throughout the text to help illustrate concepts and theory and to assist the reader in developing an intuitive sense of the subject. Readers will find many of the examples to be both entertaining and thought provoking. This is also true for the carefully selected problems that appear at the end of each chapter. This book is an excellent text for upper-level undergraduate courses. While many texts treat probability theory and statistical inference or probability theory and stochastic processes, this text enables students to become proficient in all three of these essential topics. For students in science and engineering who may take only one course in probability theory, mastering all three areas will better prepare them to collect, analyze, and characterize data in their chosen fields.

    Combinatorial Methods in Discrete Distributions

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    A unique approach illustrating discrete distribution theory through combinatorial methods This book provides a unique approach by presenting combinatorial methods in tandem with discrete distribution theory. This method, particular to discreteness, allows readers to gain a deeper understanding of theory by using applications to solve problems. The author makes extensive use of the reduction approach to conditional distributions of independent random occupancy numbers, and provides excellent studies of occupancy and sequential occupancy distributions, convolutions of truncated discrete distributions, and compound and mixture distributions. Combinatorial Methods in Discrete Distributions begins with a brief presentation of set theory followed by basic counting principles. Fundamental principles of combinatorics, finite differences, and discrete probability are included to give readers the necessary foundation to the topics presented in the text. A thorough examination of the field is provided and features: Stirling numbers and generalized factorial coefficients Occupancy and sequential occupancy distributions n-fold convolutions of truncated distributions Compound and mixture distributions Thoroughly worked examples aid readers in understanding complex theory and discovering how theory can be applied to solve practical problems. An appendix with hints and answers to the exercises helps readers work through the more complex sections. Reference notes are provided at the end of each chapter, and an extensive bibliography offers readers a resource for additional information on specialized topics.

    A History of Probability and Statistics and Their Applications before 1750

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    WILEY-INTERSCIENCE PAPERBACK SERIES The Wiley-Interscience Paperback Series consists of selected books that have been made more accessible to consumers in an effort to increase global appeal and general circulation. With these new unabridged softcover volumes, Wiley hopes to extend the lives of these works by making them available to future generations of statisticians, mathematicians, and scientists. From the Reviews of History of Probability and Statistics and Their Applications before 1750 «This is a marvelous book . . . Anyone with the slightest interest in the history of statistics, or in understanding how modern ideas have developed, will find this an invaluable resource.» –Short Book Reviews of ISI

    Quantitative Methods in Population Health

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    Each topic starts with an explanation of the theoretical background necessary to allow full understanding of the technique and to facilitate future learning of more advanced or new methods and software Explanations are designed to assume as little background in mathematics and statistical theory as possible, except that some knowledge of calculus is necessary for certain parts. SAS commands are provided for applying the methods. (PROC REG, PROC MIXED, and PROC GENMOD) All sections contain real life examples, mostly from epidemiologic research First chapter includes a SAS refresher

    Fundamentals of Probability and Statistics for Engineers

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    This textbook differs from others in the field in that it has been prepared very much with students and their needs in mind, having been classroom tested over many years. It is a true “learner’s book” made for students who require a deeper understanding of probability and statistics. It presents the fundamentals of the subject along with concepts of probabilistic modelling, and the process of model selection, verification and analysis. Furthermore, the inclusion of more than 100 examples and 200 exercises (carefully selected from a wide range of topics), along with a solutions manual for instructors, means that this text is of real value to students and lecturers across a range of engineering disciplines. Key features: Presents the fundamentals in probability and statistics along with relevant applications. Explains the concept of probabilistic modelling and the process of model selection, verification and analysis. Definitions and theorems are carefully stated and topics rigorously treated. Includes a chapter on regression analysis. Covers design of experiments. Demonstrates practical problem solving throughout the book with numerous examples and exercises purposely selected from a variety of engineering fields. Includes an accompanying online Solutions Manual for instructors containing complete step-by-step solutions to all problems.

    A First Course in Stochastic Models

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    The field of applied probability has changed profoundly in the past twenty years. The development of computational methods has greatly contributed to a better understanding of the theory. A First Course in Stochastic Models provides a self-contained introduction to the theory and applications of stochastic models. Emphasis is placed on establishing the theoretical foundations of the subject, thereby providing a framework in which the applications can be understood. Without this solid basis in theory no applications can be solved. Provides an introduction to the use of stochastic models through an integrated presentation of theory, algorithms and applications. Incorporates recent developments in computational probability. Includes a wide range of examples that illustrate the models and make the methods of solution clear. Features an abundance of motivating exercises that help the student learn how to apply the theory. Accessible to anyone with a basic knowledge of probability. A First Course in Stochastic Models is suitable for senior undergraduate and graduate students from computer science, engineering, statistics, operations resear ch, and any other discipline where stochastic modelling takes place. It stands out amongst other textbooks on the subject because of its integrated presentation of theory, algorithms and applications.

    Large Deviations for Gaussian Queues

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    In recent years the significance of Gaussian processes to communication networks has grown considerably. The inherent flexibility of the Gaussian traffic model enables the analysis, in a single mathematical framework, of systems with both long-range and short-range dependent input streams. Large Deviations for Gaussian Queues demonstrates how the Gaussian traffic model arises naturally, and how the analysis of the corresponding queuing model can be performed. The text provides a general introduction to Gaussian queues, and surveys recent research into the modelling of communications networks. Coverage includes: Discussion of the theoretical concepts and practical aspects related to Gaussian traffic models. Analysis of recent research asymptotic results for Gaussian queues, both in the large-buffer and many-sources regime. An emphasis on rare-event analysis, relying on a variety of asymptotic techniques. Examination of single-node FIFO queuing systems, as well as queues operating under more complex scheduling disciplines, and queuing networks. A set of illustrative examples that directly relate to important practical problems in communication networking. A large collection of instructive exercises and accompanying solutions. Large Deviations for Gaussian Queues assumes minimal prior knowledge. It is ideally suited for postgraduate students in applied probability, operations research, computer science and electrical engineering. The book’s self-contained style makes it perfect for practitioners in the communications networking industry and for researchers in related areas.

    Uncertainty Modeling in Dose Response

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    A valuable guide to understanding the problem of quantifying uncertainty in dose response relations for toxic substances In today's scientific research, there exists the need to address the topic of uncertainty as it pertains to dose response modeling. Uncertainty Modeling in Dose Response is the first book of its kind to implement and compare different methods for quantifying the uncertainty in the probability of response, as a function of dose. This volume gathers leading researchers in the field to properly address the issue while communicating concepts from diverse viewpoints and incorporating valuable insights. The result is a collection that reveals the properties, strengths, and weaknesses that exist in the various approaches to bench test problems. This book works with four bench test problems that were taken from real bioassay data for hazardous substances currently under study by the United States Environmental Protection Agency (EPA). The use of actual data provides readers with information that is relevant and representative of the current work being done in the field. Leading contributors from the toxicology and risk assessment communities have applied their methods to quantify model uncertainty in dose response for each case by employing various approaches, including Benchmark Dose Software methods, probabilistic inversion with isotonic regression, nonparametric Bayesian modeling, and Bayesian model averaging. Each chapter is reviewed and critiqued from three professional points of view: risk analyst/regulator, statistician/mathematician, and toxicologist/epidemiologist. In addition, all methodologies are worked out in detail, allowing readers to replicate these analyses and gain a thorough understanding of the methods. Uncertainty Modeling in Dose Response is an excellent book for courses on risk analysis and biostatistics at the upper-undergraduate and graduate levels. It also serves as a valuable reference for risk assessment, toxicology, biostatistics, and environmental chemistry professionals who wish to expand their knowledge and expertise in statistical dose response modeling problems and approaches.